# K244016: iPETcertum (v1.0)

- Pathway: 510(k) (Traditional)
- Applicant: Claritas Healthtech Pte, Ltd.
- Decided: Aug 5, 2025 after 221 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). 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)
- K213140: Claritas iPET, Claritas Healthtech Pte, Ltd. (2021) Summary page 5.

## Indications for use
iPETcertum is an image processing software intended for use by radiologists and nuclear medicine physicians for noise reduction, sharpening, resolution improvement, and optional segmentation based on uptake value in PET images (including PET/CT and PET/MRI) obtained with any kind of radionuclides, e.g. fluorodeoxyglucose (FDG). Enhanced images can be saved in DICOM, NIfTI or ECAT files and exist in conjunction with original images.

Source page: https://510kreport.com/device/K244016
Methodology: https://510kreport.com/methodology