MICSI-PET— 510(k) K261305
Substantially EquivalentMicrostructure Imaging, Inc.
FDA 510(k) clearance K261305 for MICSI-PET, Substantially Equivalent on 2026-09-11. Applicant: Microstructure Imaging, Inc.. Device class: 2.
Summary
MICSI-PET is filed under KPS, emission computed tomography systems. The record doesn't say whether it's a scanner or software, and it doesn't describe what it does.
Class II, 21 CFR 892.1200. The Radiology panel reviewed it as a Traditional 510(k).
Microstructure Imaging filed from Brooklyn, New York. Review took 144 days (April 20 to September 11, 2026).
Clearance details
- Applicant
- Microstructure Imaging, Inc.
- Product code
- Product code KPS
- Device class
- Class 2
- Regulation
- 21 CFR 892.1200
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Brooklyn, NY, US
Recent devices under product code KPS
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