FDA 510(k)

MICSI-PET

K-Number: K261305 · 2026-09-11

Decision Date2026-09-11

Product CodeKPS

Advisory CommitteeRA

DecisionSubstantially Equivalent

Device Summary

MICSI-PET is the device name listed in this FDA 510(k) record. The listed applicant is Microstructure Imaging, Inc.. It received FDA 510(k) clearance on 2026-09-11 under 510(k) number K261305. The device is classified under product code KPS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MICSI-PET?

MICSI-PET is a medical device that received FDA 510(k) clearance on 2026-09-11. The listed applicant is Microstructure Imaging, Inc.. The 510(k) number is K261305.

When did MICSI-PET receive FDA 510(k) clearance?

MICSI-PET received FDA 510(k) clearance on 2026-09-11, under 510(k) number K261305.

Who is the listed applicant for MICSI-PET?

The FDA 510(k) record lists Microstructure Imaging, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MICSI-PET?

The FDA product code for MICSI-PET is KPS.

Other records listing Microstructure Imaging, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241121MICSI-RMT

Related Devices (Code: KPS)

Official Source

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