ChestSuite 1.0.0
ChestSuite 1.0.0 is a X-ray image interpretive software (FDA Class II; FDA product code MYN, Analyzer, Medical Image) made by Imagen Technologies, Inc., cleared under FDA 510(k) K230085 on 3 Oct 2023 (2 earlier submissions) and listed in FDA GUDID since 15 Apr 2026 (UDI-DI 00852491008047), active as of 22 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 | Number00852491008047 | Date15 Apr 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK230085 | Date3 Oct 2023 | StatusActive |
Official records
- AccessGUDID record 00852491008047
- FDA 510(k) database K230085
- FDA 510(k) database K223811
- FDA 510(k) database K213353
Across registries
- FDA 510(k) K230085 decided 3 Oct 2023 Active
- FDA GUDID UDI-DI 00852491008047 listed 15 Apr 2026 Listed
Timeline
- Cleared FDA 510(k) K213353
- Cleared FDA 510(k) K223811
- Cleared FDA 510(k) K230085
- Listed FDA GUDID 00852491008047
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ChestSuite
- Generic name
- X-ray image interpretive software
- Model / reference
- 1.0.0
- Primary DI / UDI-DI
- 00852491008047
- FDA product code
- MYN
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2070
- GUDID distribution status
- In Commercial Distribution
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