# K182855: ProKnow DS

- Pathway: 510(k) (Traditional)
- Applicant: Proknow, LLC
- Decided: Jan 2, 2019 after 84 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: 13 generations back to K954874 (1996). 73 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 76 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173636: Velocity, Varian Medical Systems, Inc. (2018) Summary page 4.
- K101707: Fulaccess Model 1.0, Fulcrum Medical, Inc. (2010) Summary page 4.
- K071964: Mim 4.1 (Seastar), Mimvista Corp. (2007) Summary page 4.

## Most influential descendants
- K251363: ProKnow DS (2025), 0 descendants of its own
- K193498: Infinitt RT PACS (2020), 0 descendants of its own

## Indications for use
ProKnow DS is a patient data archive, information management, and analytics software system with a focus on the data and images specific to radiation oncology patients. Users may upload digital patient data created by other devices to ProKnow DS to securely archive, display, and analyze the data. Users can view and navigate patient images, drawn anatomy, calculated dose, and plan details derived from the source files. Users can create or edit anatomy structures to be used either prospectively (e.g., as an input to treatment planning) or retrospectively (e.g., for data analysis, research, and outcomes studies). Users can extract metrics for any single patient, or across a collection of patients, then view results as tables or graphically. ProKnow DS is to be used as an accessory system to perform data archive, review, and analysis, and is not to be used for diagnosis, treatment, or as the sole form of plan approval. Users of ProKnow DS should be trained medical professionals including, but not limited to, radiologists, oncologists, physicians, medical technologists, dosimetrists, and physicians. Users should be familiar with the different sources of input data (such as images, structure sets, treatment plans, and calculated dose) as well as how to understand and interpret derived metrics (e.g., dose-volume histograms).

Source page: https://510kreport.com/device/K182855
Methodology: https://510kreport.com/methodology