Imbio RV/LV 2.0
by Imbio, LLC
Imbio RV/LV 2.0 is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K203256 on 9 Mar 2021 and listed in FDA GUDID since 5 Apr 2021 (UDI-DI 00850894007605), 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 | Number00850894007605 | Date5 Apr 2021 | StatusListed |
| United States | FDA 510(k)SESE | NumberK203256 | Date9 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 00850894007605
- FDA 510(k) database K203256
Across registries
- FDA 510(k) K203256 decided 9 Mar 2021 Active
- FDA GUDID UDI-DI 00850894007605 listed 5 Apr 2021 Listed
Timeline
- Cleared FDA 510(k) K203256
- Listed FDA GUDID 00850894007605
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Imbio RV/LV
- Generic name
- X-ray image interpretive software
- Model / reference
- 2.0
- Primary DI / UDI-DI
- 00850894007605
- 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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