JLK-AILink
JLK, Inc. · Radiology
Open FDA's page for this record- Third party flag
- Y
- City
- Seoul
- Advisory committee description
- Radiology
- Address 1
- Jlk Tower, 5, Teheran-Ro 33-Gil
- Address 2
- Gangnam-Gu
- Statement or summary
- Summary
- Product code
- LLZ
- Zip code
- 06141
- Applicant
- JLK, Inc.
- Decision date
- 2025-02-25
- Decision code
- SESE
- Country code
- KR
- Device name
- JLK-AILink
- Advisory committee
- RA
- Contact
- Dongmin Kim
- K number
- K250348
- Date received
- 2025-02-06
- Review advisory committee
- RA
- Postal code
- 06141
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- System, Image Processing, Radiological
- Medical specialty description
- Radiology
- Regulation number
- 892.2050
- Device class
- 2
- Registration number
- 3001052305, 3005406110, 3017545364, 3005172103, 9617978, 3004706313, 3008487708, 1226544, 3009341091, 3044776706, 3010656400, 3038189169, 3007362683, 3007993775, 1061158, 3014232555, 3003757027, 3014991167, 9617592, 3013634985, 3023217364, 1054415, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 8020825, 3011676026, 3008364043, 3045521711, 3014635169, 2954921, 9615439, 3011015597, 3003989064, 3035371452, 3019544554 +603 more
- FEI number
- 3001052305, 3005406110, 3017545364, 3005172103, 3004706313, 3008487708, 3009341091, 3044776706, 3002808188, 3010656400, 3038189169, 3007362683, 3007993775, 3014232555, 3003757027, 3014991167, 3013634985, 3023217364, 3013535906, 3026047529, 3019878658, 3005225421, 3030655434, 3009156722, 3010445368, 3011676026, 3008364043, 3045521711, 3014635169, 3011015597, 3003989064, 3035371452, 3019544554, 3008548323, 3014269683, 3002821504, 2126677, 3002619595, 3010684280, 3003861317 +603 more