Micsi-Rmt 1
by Microstructure Imaging, Inc.
Micsi-Rmt 1 is a medical device (FDA Class II; FDA product code LLZ, System, Image Processing, Radiological) made by Microstructure Imaging, Inc., cleared under FDA 510(k) K241121 on 17 Jul 2024 and listed in FDA GUDID since 30 Apr 2025 (UDI-DI 00860013868901), 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 | Number00860013868901 | Date30 Apr 2025 | StatusListed |
| United States | FDA 510(k)SESE | NumberK241121 | Date17 Jul 2024 | StatusActive |
Official records
- AccessGUDID record 00860013868901
- FDA 510(k) database K241121
Across registries
- FDA 510(k) K241121 decided 17 Jul 2024 Active
- FDA GUDID UDI-DI 00860013868901 listed 30 Apr 2025 Listed
Timeline
- Cleared FDA 510(k) K241121
- Listed FDA GUDID 00860013868901
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Micsi-Rmt
- Generic name
- Radiology DICOM image processing application software
- Model / reference
- 1
- Primary DI / UDI-DI
- 00860013868901
- 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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