# K211964: SubtlePET

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Sep 28, 2021 after 96 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: 5 generations back to K922470 (1992). 5 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182336: SubtlePET, Subtle Medical, Inc. (2018) Summary page 4.

## Most influential descendants
- K261305: Micsi-Pet (2026), 0 descendants of its own
- K254013: SubtleHD-PET (1.x) (2026), 0 descendants of its own

## Indications for use
SubtlePET is an image processing software intended for use by radiologists and nuclear medicine physicians for transfer, storage, and noise reduction of fluorodeoxyglucose (FDG), amyloid, 18F-DOPA, 18F-DCFPyL, Ga-68 Dotatate, and Ga-68 PSMA radiotracer PET images.

Source page: https://510kreport.com/device/K211964
Methodology: https://510kreport.com/methodology