Micsi-Pet 1
by Microstructure Imaging, Inc.
Micsi-Pet 1 is a medical device (FDA Class II) made by Microstructure Imaging, Inc., cleared under FDA 510(k) K261305 on 11 Sep 2026 and listed in FDA GUDID since 14 Oct 2026 (UDI-DI 00860013868918), active as of 2 Nov 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 | Number00860013868918 | Date14 Oct 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK261305 | Date11 Sep 2026 | StatusActive |
Official records
- AccessGUDID record 00860013868918
- FDA 510(k) database K261305
Across registries
- FDA 510(k) K261305 decided 11 Sep 2026 Active
- FDA GUDID UDI-DI 00860013868918 listed 14 Oct 2026 Listed
Timeline
- Cleared FDA 510(k) K261305
- Listed FDA GUDID 00860013868918
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micsi-Pet
- Generic name
- Nuclear medicine clinical assessment support software
- Model / reference
- 1
- Primary DI / UDI-DI
- 00860013868918
- 510(k) Number
- FDA product code
- LLZ, KPS
- GMDN term
- Nuclear medicine clinical assessment support software
- Device class
- Class II
- Regulation number
- 892.2050, 892.1200
- GUDID distribution status
- In Commercial Distribution
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