# K182336: SubtlePET

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: Nov 30, 2018 after 94 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: 4 generations back to K922470 (1992). 4 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063391: Sapheneia Clarity, Sapheneia Commercial Products AB (2007) Summary page 4.

## Most influential descendants
- K213140: Claritas iPET (2021), 2 descendants of its own
- K211964: SubtlePET (2021), 2 descendants of its own
- K261305: Micsi-Pet (2026), 0 descendants of its own
- K254013: SubtleHD-PET (1.x) (2026), 0 descendants of its own
- K244016: iPETcertum (v1.0) (2025), 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) and amyloid PET images (including PET/CT and PET/MRI).

Source page: https://510kreport.com/device/K182336
Methodology: https://510kreport.com/methodology