EXTRON 3;EXTRON 6
DRTECH Corporation · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Seongnam-Si
- Advisory committee description
- Radiology
- Address 1
- Suite #1, 2 Floor /Suite # 2, 3 Floor, 29
- Address 2
- Dunchon-Daero 541 Beon-Gil, Jungwon-Gu
- Statement or summary
- Summary
- Product code
- OWB
- Zip code
- 13216
- Applicant
- DRTECH Corporation
- Decision date
- 2026-08-19
- Decision code
- SESE
- Country code
- KR
- Device name
- EXTRON 3;EXTRON 6
- Advisory committee
- RA
- Contact
- Youngeun Lee
- K number
- K261413
- Date received
- 2026-04-30
- Review advisory committee
- RA
- Postal code
- 13216
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Interventional Fluoroscopic X-Ray System
- Medical specialty description
- Radiology
- Regulation number
- 892.1650
- Device class
- 2
- Registration number
- 1723170, 1835251, 3008632256, 3023003446, 3005843418, 3015223550, 3010462278, 3027339477, 3001722928, 1225677, 1052701, 3012624817, 3009144915, 3021060474, 3009001657, 3006128100, 3012761544, 9611343, 1720753, 3021561977, 3003935342, 2031966, 3010398867, 3016438694, 3008363989, 8043933, 3018077344, 1000188474, 3031503890, 3033525986, 9681146, 1037955, 3004977335, 3013944123, 3036666444, 1054713, 3010703925, 9613445, 3008284470, 3021559833 +85 more
- FEI number
- 3002980729, 3008632256, 3023003446, 3005843418, 3015223550, 3010462278, 3002807880, 3027339477, 3001722928, 3001451453, 3012624817, 3009144915, 3021060474, 3009001657, 3006128100, 3012761544, 1720753, 3021561977, 3003935342, 3010398867, 3002619595, 3016438694, 3008363989, 3018077344, 1000188474, 3031503890, 3033525986, 1037955, 3004977335, 3013944123, 3036666444, 3010703925, 3008284470, 3021559833, 3008044777, 3021027284, 3008496839, 3033527282, 3002807041, 3012957335 +85 more