510(k) clearance

MICSI-PET

FDA 510(k) source

510(k) number

K261305

Applicant

Microstructure Imaging, Inc.

Decision date

Sep 11, 2026

Date received

Apr 20, 2026

Decision

Substantially Equivalent

Clearance type

Traditional

Product code

KPS

Device type

System, Tomography, Computed, Emission

Device class

Class II

Regulation

21 CFR 892.1200

Advisory committee

Radiology

Statement or summary

Summary

Third party

N

Location

Brooklyn, NY, US