• Journal of radiological science and technology
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• v.39 no.4
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• pp.651-660
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• 2016

Due to recent population aging, the number of check-up for senior citizens has increased steadily. According to this trend, the market size of dental X-ray equipment and the number of approval and review for these devices have simultaneously increased. The technical document of medical device is required for approval and review for medical device, and medical device companies needs to have work comprehension and expertise, as the document needs to include the overall contents such as performances, test criteria, etc.. Yet, since most of domestic manufacturers or importers of medical devices are small businesses, it is difficult for them to recruit professional manpower for approval of medical devices, and submission of inaccurate technical documents has increased. These problems lead to delay of the approval process and to difficulties in quick entering into the market. Especially, the Ministry of Food and Drug safety (MFDS) standards of a dental extra-oral X-ray equipment, a dental intra-oral X-ray equipment, an arm-type computed tomography, and a portable X-ray system have been recently enacted or not. this guideline of dental X-ray equipment adjusting revised standards was developed to help relative companies and reviewers. For this study, first, the methods to write technical document have been reviewed with revised international and domestic regulations and system. Second, the domestic and foreign market status of each item has been surveyed and analyzed. Third, the contents of technical documents already approved by MFDS have been analyzed to select the correct example, test items, criteria, and methods. Finally, the guideline has been developed based on international and domestic regulation, through close review of a consultative body composed of academic, industrial, research institute and government experts.

• Analytical Science and Technology
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• v.27 no.5
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• pp.234-242
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• 2014

Imicyafos which is a nematicide for controlling root-knot nematodes has been registered in the Republic of Korea in 2012, and the maximum residue limits of imicyafos are set to watermelon and korean melon as each 0.05 mg/kg. Extremely reliable and sensitive analytical method is required for ensuring food safety on imicyafos residues in agricultural commodities. Imicyafos residues in samples were extracted with acetone, partitioned with hexane and dichloromethane, and then purified with florisil. The purified samples were analyzed by HPLC-UVD and confirmed with LC-MS. Linear range was between 0.1~5 mg/kg with the correlation coefficient ($r^2$) 0.99997. Average recoveries of imicyafos ranged from 77.0 to 115.4% at the spiked levels of 0.02 and 0.05 mg/kg with the relative standard deviations of 2.2~9.6%. Limit of detection and quantification were 0.005 and 0.02 mg/kg, respectively. An inter-laboratory study was conducted to validate the determination method in depth, and the results were satisfactory. All of the validation results revealed that the developed analytical method in this study is relevant for imicyafos determination in agricultural commodities and will be used as an official analytical method.

• Journal of the Society of Cosmetic Scientists of Korea
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• v.39 no.3
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• pp.241-249
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• 2013

This study was aimed to provide the fundamental data about oxidized hair color products. For this reason, we collected 125 oxidized hair color products, which were distributed in domestic market from January to October, 2012, and measured the heavy metal concentrations of lead, arsenic, cadmium, chromium, manganese, nickel, copper in the samples. Results were compared by domestic, foreign, henna, type and color. The average metal concentrations were as follows; 0.211 ${\mu}g/g$ for lead, 0.008 ${\mu}g/g$ for cadmium, 0.051 ${\mu}g/g$ for arsenic, 0.954 ${\mu}g/g$ for chromium, 6.250 ${\mu}g/g$ for manganese, 0.591 ${\mu}g/g$ for nickel and 0.544 ${\mu}g/g$ for copper. In case of lead and arsenic, the concentrations were much less than the regulated amount (20 ${\mu}g/g$ and 10 ${\mu}g/g$, respectively) suggested by MFDS (Ministry of Food and Drug Safety). In henna (p < 0.05), the concentrations were significantly higher than those of other domestic and foreign oxidized hair color products as follows; 1.264 ${\mu}g/g$ for lead, 0.267 ${\mu}g/g$ for arsenic, 0.025 ${\mu}g/g$ for cadmium, 4.055 ${\mu}g/g$ for chromium, 72.044 ${\mu}g/g$ for manganese, 3.076 ${\mu}g/g$ for nickel and 4.640 ${\mu}g/g$ for copper. Statistically, it showed that the heavy metal concentrations were quite different for the different types of hair color products. The cream and liquid type products had the highest average concentration in chromium (0.708 ${\mu}g/g$, 0.478 ${\mu}g/g$, respectively). On the other hand, powder type products showed the highest concentration in manganese (60.041 ${\mu}g/g$). In addition, the concentrations of heavy metals and the color of products are not quite correlated. It was shown that average concentrations of lead and chromium were higher for yellow, chromium for red and pink, manganese for brown and black, and nickel for green.

• Journal of the East Asian Society of Dietary Life
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• v.26 no.6
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• pp.507-516
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• 2016

The salinity of soups of institutions enrolled at the Center for Children's Foodservice Management was monitored to reduce sodium intake of children by continuously managing salinity of soups provided by children food service. Monitoring of salinity was conducted by a salinity meter (SB-1500H, HM digital) three times in 2016 by patrolling children's institutions for the instruction of public health. The average salinity of soups provided by total children's institution showed a significant decrease in salinity - $1^{st}$ 0.45%, $2^{nd}$ 0.41% and $3^{rd}$ 0.39% - as monitoring was proceeded (p<0.01). When salinity of soups was analyzed according to the type of children's institution, the salinity of national and public institutions showed no significant decrease. In contrast, the salinity of private institutions decreased significantly (p<0.05). Depending on the enrollment of the food service, there was no significant difference in average salinity of soups between large food services, which have over 50 children, and small food services, which have less than 50 children. However, all food services showed a salinity decrease from the $1^{st}$ monitoring to the $3^{rd}$ monitoring. Salinity according to the type of soup showed that salinity of clear soup, miso soup, and stew except beef soup decreased from the $1^{st}$ monitoring to $3^{rd}$ monitoring. However, there was no significant difference in salinity according to the type of soup which can be attributed to a large difference in salinity among the same type of soup. The individual soup showing the biggest difference between maximum and minimum salinity of soup was egg soup (0.62%), potato soup (0.54%), and mushroom soup (0.64%). The present average salinity of soup provided by children's institutions was less than 0.5% which is the recommended standard of the Ministry of Food and Drug Safety. However, the salinity of soups should be managed within a certain range including the minimum salinity regarding the taste education of children.

• The Journal of Korea Institute of Information, Electronics, and Communication Technology
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• v.14 no.5
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• pp.394-402
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• 2021

The entry of an aging society and the extension of human life expectancy, the increasing interest in women's social advancement and men's appearance, and the natural interest in K-culture through media media, while receiving worldwide attention, Focus on K-Bueaty. Recently, looking at the occupation of the medical tourism field, in the case of aesthetic medicine tourism such as molding and dermatology, it has gained popularity not only in Asia such as China and Japan, but also in North America and Europe. The first external confirmation of human aging is the wrinkles on the skin of the face. Clean, wrinkle-free, elastic and healthy skin is a desire of most people. Skin condition and condition such as focused ultrasonic stimulation (HIFU: High Intensity Focused Utrasound) and low frequency, high frequency (RF: Radio Frequency), galvanic therapy using microcurrent, cryotherapy using rapid cooling, etc. Depending on the method of management, the effect of the treatment differs depending on the output and the stimulation site, etc., even in the treatment of medical equipment and beauty equipment using the same mechanism. In this research, in order to develop invasive high-frequency dermatological devices using a large number of beauty medical devices and microneedles of beauty devices, the international standards IEC 60601-2 (standards for individual medical devices) and MFDS (Ministry of) We designed and developed a high-frequency output device in compliance with the high-frequency stimulation standard announced in the Food and Drug Safety (Ministry of Food and Drug Safety). The circuit design consists of an amplifier (AMP: Amplifier) using Class-A Topology and a power supply device using Half-Bridge Topology. As a result of measuring the developed high-frequency output device, an average efficiency of 63.86% was obtained, and the maximum output was measured at 116.7W and 50.67dBm.

• Journal of the Korean Society of Radiology
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• v.17 no.6
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• pp.881-887
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• 2023

This study aims to analyze the development and current trends of AI-based medical imaging devices commercialized in South Korea. As of September 30, 2023, there were a total of 186 AI-based medical devices licensed, certified, and reported to the Korean Ministry of Food and Drug Safety, of which 138 were related to imaging. The study comprehensively examined the yearly approval trends, equipment types, application areas, and key functions from 2018 to 2023. The study found that the number of AI medical devices started from four products in 2018 and grew steadily until 2023, with a sharp increase after 2020. This can be attributed to the interaction between the advancement of AI technology and the increasing demand in the medical field. By equipment, AI medical devices were developed in the order of CT, X-ray, and MR, which reflects the characteristics and clinical importance of the images of each equipment. This study found that the development of AI medical devices for specific areas such as the thorax, cranial nerves, and musculoskeletal system is active, and the main functions are medical image analysis, detection and diagnosis assistance, and image transmission. These results suggest that AI's pattern recognition and data analysis capabilities are playing an important role in the medical imaging field. In addition, this study examined the number of Korean products that have received international certifications, particularly the US FDA and European CE. The results show that many products have been certified by both organizations, indicating that Korean AI medical devices are in line with international standards and are competitive in the global market. By analyzing the impact of AI technology on medical imaging and its potential for development, this study provides important implications for future research and development directions. However, challenges such as regulatory aspects, data quality and accessibility, and clinical validity are also pointed out, requiring continued research and improvement on these issues.

• The Korean Journal of Food And Nutrition
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• v.30 no.3
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• pp.539-551
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• 2017

This study investigated the current status and needs for nutrition education to help reduce children's sugars intake at the Center for Children's Foodservice Management (CCFM, n=115), and Child Care Facilities (CCF, n=646) through an online survey conducted from October $5^{th}$ to $30^{th}$ 2015. A total of 14.8% of CCFM respondents and 31.9% of CCF respondents provided nutrition education on sugars intake to young children as a main topic (p<0.001). A higher percentage (CCFM 47.8%: CCF 42.4%) delivered nutrition education on sugars intake to young children as a sub-component (p<0.001). Over 90% of the CCFM and CCF participants agreed on the necessity of providing nutrition education on sugars intake to children. The most common reasons given for delivering nutrition education on children's sugar intake were "there are many more urgent nutrition education topics" for CCFM, and "insufficient nutrition education information and materials" for CCF. The percentage of nutrition education on children's sugar intake provided to the children's parents was low showing about 20% in the both groups. The percentage of CCFM participants providing nutrition, education on children's sugar intake to the teachers in CCF was also low, showing about 14.8%; however, 68.0% of the CCF participants wanted to received teacher's education on guiding children's sugar intake. Regarding ideas about a nutrition education program on children's sugar intake for young children, most respondents in both groups answered "sugar intake and dental cavities or obesity" for appropriate education contents, "story telling or puppet show" for appropriate education methods, and "dietitian from CCFM and class teacher together" for appropriate educator. For appropriate education time, there was a significantl difference between the CCFM responses (average 2.7 times) and the CCF responses (average 4 times). Based on the above results, we found that implementing nutrition education on children's sugar intake at the CCFM and CCF, was low; however, awareness of the need for nutrition education on children's sugar intake and the program development and supply was very high. Also, the opinions of CCFM and CCF participants about a nutrition education program on children's sugar intake for young children can provide foundation data to develop and implement the CCFM-based nutrition education program.