Cleared Traditional

K261305 - MICSI-PET

K261305 is an FDA 510(k) clearance for MICSI-PET, manufactured by Microstructure Imaging, Inc.. The device is a Class 2 Radiology device with product code KPS cleared through the Traditional 510(k) pathway after a 144-day FDA review.

K261305 · Microstructure Imaging, Inc. · Radiology device
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Sep 2026
Decision
144d
Days
Class 2
Risk

K261305 is an FDA 510(k) clearance for the MICSI-PET. Classified as System, Tomography, Computed, Emission (product code KPS), Class II - Special Controls.

Submitted by Microstructure Imaging, Inc. (Brooklyn, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 144 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1200 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Microstructure Imaging, Inc. devices

FDA 510(k) Submission Details - K261305

510(k) Number K261305 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 20, 2026
Decision Date September 11, 2026
Days to Decision 144 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
37d slower than avg
Panel avg: 107d · This submission: 144d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPS Device Classification - Class 2, Special Controls

Product Code KPS System, Tomography, Computed, Emission
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1200
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Consultant

Highland Biomedical, Inc.
Adam Heroux

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KPS System, Tomography, Computed, Emission

All 404
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