BoneView
by Gleamer
Ref BoneViewModel BoneView / ChestView
BoneView is a medical device (EU MDR Class IIa) made by Gleamer Sas, registered in EUDAMED on 17 Oct 2023 (Basic UDI-DI 377002083900003AJ) and cleared under FDA 510(k) K222176 on 2 Mar 2023 (1 earlier submission), active as of 25 Oct 2026.
Active
CE MDR 510(k)
Valid until
No date given
FDA recalls
None found
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| European Union | CE/MDR EUDAMED | Number377002083900003AJ 03770020839061 | Date17 Oct 2023 | StatusActive |
| United States | FDA 510(k) 510(k) | NumberK222176 | Date2 Mar 2023 | StatusActive |
Official records
- EUDAMED public site 377002083900003AJ
- FDA 510(k) database K222176
- FDA 510(k) database K212365
Across registries
- EUDAMED Basic UDI-DI 377002083900003AJ registered 17 Oct 2023 Active
- FDA 510(k) K222176 decided 2 Mar 2023 Active
Timeline
- Cleared FDA 510(k) K212365
- Cleared FDA 510(k) K222176
- Registered EUDAMED 377002083900003AJ
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
- United States
- European Union
Specification
- Model / reference
- BoneView / ChestView, BoneView
- Primary DI / UDI-DI
- 03770020839061
- Basic UDI-DI
- 377002083900003AJ
- EMDN code
- Z11039082 Various radiodiagnostic and interventional instruments - software accessories
- Device class
- Class IIa
- Special device type
- Software
- EU registration type
- Standard device
- EU market of registration
- France
Manufacturer details
- EUDAMED SRN
- FR-MF-000011358
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