Imbio SET 1.0.3.3
by Imbio, LLC
Imbio SET 1.0.3.3 is a Class II device made by Imbio, LLC, cleared under FDA 510(k) K180129 on 16 Mar 2018 and listed in FDA GUDID since 25 Sep 2019 (UDI-DI 00850894007445), 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 | Number00850894007445 | Date25 Sep 2019 | StatusListed |
| United States | FDA 510(k)SESE | NumberK180129 | Date16 Mar 2018 | StatusActive |
Official records
- AccessGUDID record 00850894007445
- FDA 510(k) database K180129
Across registries
- FDA 510(k) K180129 decided 16 Mar 2018 Active
- FDA GUDID UDI-DI 00850894007445 listed 25 Sep 2019 Listed
Timeline
- Cleared FDA 510(k) K180129
- Listed FDA GUDID 00850894007445
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Imbio SET
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1.0.3.3
- Primary DI / UDI-DI
- 00850894007445
- 510(k) Number
- FDA product code
- LLZ
- GMDN term
- Radiology DICOM image processing application software
- Device class
- Class II
- Regulation number
- 892.2050
- GUDID distribution status
- In Commercial Distribution
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