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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261305

510(k) cleared

MICSI-PET

Microstructure Imaging, Inc. · Sep 11, 2026 · K261305 · In the directory

FDA cleared the MICSI-PET from Microstructure Imaging, Inc. on Sep 11, 2026 under K261305, a traditional 510(k). The device falls under product code KPS, System, Tomography, Computed, Emission, regulated at 21 CFR 892.1200 as a Class 2 device. The review panel was Radiology.

FDA logged the submission as received on Apr 20, 2026. The decision came 144 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Microstructure Imaging, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261305?

K261305 is the FDA 510(k) for MICSI-PET, submitted by Microstructure Imaging, Inc.. FDA's decision date was Sep 11, 2026, under product code KPS (System, Tomography, Computed, Emission).

Who makes the MICSI-PET?

Microstructure Imaging, Inc., based in Brooklyn, NY, is the applicant of record for K261305. The company is listed in the MedDevice Startups directory.

How long did the K261305 review take?

FDA received the submission on Apr 20, 2026 and issued its decision on Sep 11, 2026, 144 days later.

← All decisions in September 2026

Sources

In the startup directory

Microstructure Imaging

Imaging & Radiology · Brooklyn, NY