ExamVue Apex
Jpi Healthcare Co, Ltd. · Radiology
Open FDA's page for this record- Third party flag
- N
- City
- Seoul
- Advisory committee description
- Radiology
- Address 1
- 608-Ho, 28, Digital-Ro 33 Gil, Guro-Gu
- Statement or summary
- Summary
- Product code
- MQB
- Zip code
- 08377
- Applicant
- Jpi Healthcare Co, Ltd.
- Decision date
- 2025-02-24
- Decision code
- SESE
- Country code
- KR
- Device name
- ExamVue Apex
- Advisory committee
- RA
- Contact
- Jeongjoon Lee
- K number
- K244010
- Date received
- 2024-12-26
- Review advisory committee
- RA
- Postal code
- 08377
- Decision description
- Substantially Equivalent
- Clearance type
- Traditional
- Harmonized identifiers (openFDA)
- Device name
- Solid State X-Ray Imager (Flat Panel/Digital Imager)
- Medical specialty description
- Radiology
- Regulation number
- 892.1680
- Device class
- 2
- Registration number
- 3005406110, 3030898585, 3012624817, 3005172103, 3001556265, 3004706313, 3015223550, 9613152, 3003768277, 3015464948, 3017375271, 1721964, 8020997, 1054713, 9617251, 9616014, 3027605321, 3003528079, 3008284470, 3031503890, 8021091, 3001722928, 3014209556, 3006551157, 3013679558, 1450503, 9615439, 3011015597, 3006529712, 3013186032, 3011471624, 3004977335, 2126677, 3005560996, 3009532935, 3017004860, 3005254598, 3007065358, 3006542593, 3008304180 +87 more
- FEI number
- 3005406110, 3030898585, 3012624817, 3005172103, 3001556265, 3004706313, 3015223550, 3015464948, 3017375271, 3003377038, 3002808461, 3004084693, 3002808382, 3027605321, 3003528079, 3008284470, 3005116291, 3031503890, 3001722928, 3014209556, 3006551157, 3013679558, 1450503, 3011015597, 3006529712, 3013186032, 3011471624, 1000117423, 3004977335, 2126677, 3002175190, 3009532935, 3005560996, 3008875470, 3003861317, 3017004860, 3005254598, 3007065358, 3006542593, 3016674851 +87 more