# K161625: PixelShine

- Pathway: 510(k) (Traditional)
- Applicant: Algomedica
- Decided: Sep 19, 2016 after 98 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: 4 generations back to K922470 (1992). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100372: Safect Model Ver 1.0, Medic Vision Brain Technologies, Ltd. (2010) Summary page 4.

## Indications for use
The AlgoMedica PixelShine System is intended for networking, communication, processing and enhancement of CT images in DICOM format. It is specifically indicated for assisting professional radiologists and specialists in reaching their own diagnosis. The device processing is not effective for lesion, mass or abnormalities of sizes less than 3.0 mm The AlgoMedica PixelShine is not intended for use with or for diagnostic interpretation of mammography images.

Source page: https://510kreport.com/device/K161625
Methodology: https://510kreport.com/methodology