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Micsi-Pet

by Microstructure Imaging, Inc.

510(k) K261305

Micsi-Pet is a medical device (FDA Class II; FDA product code KPS, System, Tomography, Computed, Emission) made by Microstructure Imaging, Inc., cleared under FDA 510(k) K261305 on 11 Sep 2026, active as of 22 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK261305 Date11 Sep 2026ClearedStatusActive

Official records

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
KPS
Device class
Class II
Regulation
21 CFR Part 892.1200
Advisory committee
Radiology
FDA decision
SESE Substantially Equivalent

Devices cleared under K261305

1 device · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K261305
UDI-DISize and differences
MICSI-PET 1
Microstructure Imaging, Inc.
100860013868918 —On the market

Similar devices

Other devices filed under FDA product code KPS (System, Tomography, Computed, Emission).

Other devices from Microstructure Imaging, Inc.

  • Micsi-Pet 1

    Class II

  • Micsi-Rmt 1

    Class II

  • Micsi-Rmt

    Class II