Imbio PHA 4.0.0
by Imbio, LLC
Imbio PHA 4.0.0 is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K241847 on 30 Aug 2024 and listed in FDA GUDID since 21 Apr 2025 (UDI-DI 00850894007902), 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 | Number00850894007902 | Date21 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241847 | Date30 Aug 2024 | StatusActive |
Official records
- AccessGUDID record 00850894007902
- FDA 510(k) database K241847
Across registries
- FDA 510(k) K241847 decided 30 Aug 2024 Active
- FDA GUDID UDI-DI 00850894007902 listed 21 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K241847
- Listed FDA GUDID 00850894007902
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Imbio PHA
- Generic name
- X-ray image interpretive software
- Model / reference
- 4.0.0
- Primary DI / UDI-DI
- 00850894007902
- 510(k) Number
- FDA product code
- QIH
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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