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 code covers PET and SPECT scanners as well as the software that processes their images, and the record doesn't say which this is. Given the applicant's name, Microstructure Imaging, analysis or reconstruction software seems more likely than a scanner.
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), a normal timeline for radiology software under this regulation.
Clearance details
- Applicant
- Microstructure Imaging, Inc.
- Product code
- 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
view allMore clearances from Microstructure Imaging, Inc.
view allData sourced from openFDA. This site is unofficial and independent of the FDA.