# K063391: Sapheneia Clarity

- Pathway: 510(k) (Traditional)
- Applicant: Sapheneia Commercial Products AB
- Decided: Apr 26, 2007 after 168 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: 3 generations back to K922470 (1992). 3 ancestors in all.
9 later devices descend from it; 4 cite it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K024028: Sharp View Image Enhancement System, Context Vision AB (2003) Summary page 2.

## Most influential descendants
- K182336: SubtlePET (2018), 5 descendants of its own
- 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

## Indications for use
The Sapheneia Clarity is intended for use by radiologists for transfer, storage, noise reduction, contrast enhancement and viewing of multi-modality images from a variety of diagnostic systems. The device is also intended to be used by trained/qualified technologists for installation and maintenance of the software. For your legal protection, it is strongly recommended that you backup your original data. For digital mammography, only DICOM 'For Presentation' images should be displayed for primary image diagnosis

Source page: https://510kreport.com/device/K063391
Methodology: https://510kreport.com/methodology