# K193306: PROView

- Pathway: 510(k) (Traditional)
- Applicant: GE Medical Systems SCS
- Decided: Nov 17, 2020 after 354 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: 2 generations back to K121517 (2012). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K192200: DynaCAD, Invivo Corporation (2019) Summary page 5.

## Indications for use
PROView is an aiding tool for the clinicians to review multi-parametric prostate magnetic resonance (MR) images following PI-RADS guidelines. It displays acquired and reformatted data for visualization and provides tools for assessment of the prostate gland volume and findings analysis in patients with known or suspected prostate lesions. Measurements and associated scoring are included in a report for communication to referring physicians. It is intended for use by professionals, such as clinicians, radiologists, or physicians. The clinician remains ultimately responsible for the final assessment and diagnosis based on state-of-the-art practices, clinical judgment and interpretation of prostate images or quantitative data.

Source page: https://510kreport.com/device/K193306
Methodology: https://510kreport.com/methodology