# K254013: SubtleHD-PET (1.x)

- Pathway: 510(k) (Traditional)
- Applicant: Subtle Medical, Inc.
- Decided: May 14, 2026 after 150 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- 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). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K213140: Claritas iPET, Claritas Healthtech Pte, Ltd. (2021) Summary page 5.
- K211964: SubtlePET, Subtle Medical, Inc. (2021) Summary page 5.

## Indications for use
SubtleHD-PET is an image processing software intended for noise reduction of PET images (including PET/CT and PET/MR) obtained with any kind of radiotracer (e.g. 18F-FDG).

Source page: https://510kreport.com/device/K254013
Methodology: https://510kreport.com/methodology