Koala V2.05
by IB Lab GmbH
Koala V2.05 is a Class II device made by IB Lab GmbH, cleared under FDA 510(k) K192109 on 5 Nov 2019 and listed in FDA GUDID since 3 Nov 2020 (UDI-DI 09120105730037), active (FDA 510(k)), not in commercial distribution (GUDID) 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 | Number09120105730037 | Date3 Nov 2020 | StatusListed |
| United States | FDA 510(k)SESE | NumberK192109 | Date5 Nov 2019 | StatusActive |
Official records
- AccessGUDID record 09120105730037
- FDA 510(k) database K192109
Across registries
- FDA 510(k) K192109 decided 5 Nov 2019 Active
- FDA GUDID UDI-DI 09120105730037 listed 3 Nov 2020 Listed
Timeline
- Cleared FDA 510(k) K192109
- Listed FDA GUDID 09120105730037
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Koala
- Generic name
- X-ray image interpretive software
- Model / reference
- V2.05
- Primary DI / UDI-DI
- 09120105730037
- 510(k) Number
- FDA product code
- LLZ, JAK
- GMDN term
- X-ray image interpretive software
- Device class
- Class II
- Regulation number
- 892.2050, 892.1750
- GUDID distribution status
- Not in Commercial Distribution
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