ChestView US 1.1.X
by Gleamer Sas
ChestView US 1.1.X is a radiological PACS-dedicated management software (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Gleamer Sas, cleared under FDA 510(k) K252486 on 9 Sep 2026 and listed in FDA GUDID since 22 Sep 2026 (UDI-DI 03770020839153), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number03770020839153 | Date22 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK252486 | Date9 Sep 2026 | StatusActive |
Official records
- AccessGUDID record 03770020839153
- FDA 510(k) database K252486
Across registries
- FDA 510(k) K252486 decided 9 Sep 2026 Active
- FDA GUDID UDI-DI 03770020839153 listed 22 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K252486
- Listed FDA GUDID 03770020839153
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ChestView US
- Generic name
- Radiological PACS-dedicated management software
- Model / reference
- 1.1.X
- Primary DI / UDI-DI
- 03770020839153
- 510(k) Number
- FDA product code
- MYN
- GMDN term
- Radiological PACS-dedicated management software
- Device class
- Class II
- Regulation number
- 892.2070
- GUDID distribution status
- In Commercial Distribution
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