# K213140: Claritas iPET

- Pathway: 510(k) (Traditional)
- Applicant: Claritas Healthtech Pte, Ltd.
- Decided: Dec 22, 2021 after 86 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: 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
- K254013: SubtleHD-PET (1.x) (2026), 0 descendants of its own
- K244016: iPETcertum (v1.0) (2025), 0 descendants of its own

## Indications for use
Claritas iPET is an image processing software intended for use by radiologists and nuclear medicine physicians for noise reduction, sharpening, and resolution improvement of PET images (including PET/CT and PET/MRI) obtained with any kind of radionuclides, e.g. fluorodeoxyglucose (FDG). Enhanced images will be saved in DICOM files and exist in conjunction with original images.

Source page: https://510kreport.com/device/K213140
Methodology: https://510kreport.com/methodology