# K261305: Micsi-Pet

- Pathway: 510(k) (Traditional)
- Applicant: Microstructure Imaging, Inc.
- Decided: Sep 11, 2026 after 144 days
- Product code: KPS (System, Tomography, Computed, Emission)
- Device class: 2
- Regulation: 21 CFR 892.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922470 (1992). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211964: SubtlePET, Subtle Medical, Inc. (2021) Summary page 5.

## Indications for use
MICSI-PET is an image processing software that can be used for image enhancement in PET images. It computes quantitative metrics including regional SUVr (Standardized Uptake Value ratio), Centiloid scores for amyloid and tau PET, and z-scores compared to normative controls.

Source page: https://510kreport.com/device/K261305
Methodology: https://510kreport.com/methodology