# K251363: ProKnow DS

- Pathway: 510(k) (Traditional)
- Applicant: Elekta Solutions AB
- Decided: Oct 8, 2025 after 160 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: 14 generations back to K954874 (1996). 74 ancestors in all.
No later device cites it as a predicate yet.
0 of 75 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K182855: ProKnow DS, Proknow, LLC (2019) Summary page 5.

## Indications for use
ProKnow DS is intended to be a data archive and processing software which supports review, analytics, and clinical decision-making with a focus on the data specific to radiation oncology patients. ProKnow DS should be used in healthcare facilities by trained medical professionals including, but not limited to physicians, medical technologists, physicists and dosimetrists.

Source page: https://510kreport.com/device/K251363
Methodology: https://510kreport.com/methodology