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ChestView
EUDAMEDFDA 510(k)Class IIa (EU MDR)
Ref ChestViewModel BoneView / ChestView510(k) K241620
by Gleamer
Identity
- Trade Name
- ChestView EUDAMED
- Model / Reference
- BoneView / ChestView EUDAMEDChestView EUDAMED
Identifiers
- Primary DI / UDI-DI
- 03770020839078 EUDAMED
- Basic UDI-DI
- 377002083900003AJ EUDAMED
- 510(k) Number
- K241620 FDA 510(k)
- FDA Product Code
- MYN FDA 510(k)
- EMDN Code
- Z11039082 VARIOUS RADIODIAGNOSTIC AND INTERVENTIONAL INSTRUMENTS - SOFTWARE ACCESSORIES EUDAMED
Classification
- Device Class
- Class IIa EUDAMEDClass II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 892.2070 FDA 510(k)
- Regulation Number
- 892.2070 FDA 510(k)
- Special Device Type
- Software EUDAMED
- Market of Registration
- France EUDAMED
- Advisory Committee
- Radiology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ChestView by Gleamer — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K241620 | Class IIa | Active |
| EUDAMED | European Union | CE/MDR | 377002083900003AJ | Class IIa | Active |
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Manufacturer
- Manufacturer
- Gleamer
- EUDAMED SRN
- FR-MF-000011358
Sources (2)
- EUDAMED aacf12c9-2ce0-4389-b137-4b9d8d1270c5 61 fields · synced Jul 22, 2026
- FDA 510(k) K241620 24 fields · synced May 18, 2026