# K993750: Prosolv Echoviewer, Prosolv Echoviewer SE, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv Echo

- Pathway: 510(k) (Traditional)
- Applicant: Problem Solving Concepts, Inc.
- Decided: Feb 2, 2000 after 89 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) HP 5500 Sonos (EnConcert software): named in the summary without a submission number
- (no number) Digisonics’ Doctor Review System (DigiView System): named in the summary without a submission number

## Indications for use
ProSolv® Echo is stand-alone software that operates on standard PC equipment. The device is available in three configurations (EchoViewer, EchoViewer SE, and EchoAnalyzer) and is intended for use by echocardiographic labs ProSolv® EchoViewer is also intended for use by cardiac catheterization labs. ProSolv® Echo incorporates the latest technology in archiving, viewing, measuring, analyzing, and reporting digital echocardiographic studies generated by a multitude of ultrasound manufacturers. The device configurations can be packaged with ProSolv® EchoServer to extend the capabilities for laboratories wanting to access a remote, secure database and archive images over the Internet.

Source page: https://510kreport.com/device/K993750
Methodology: https://510kreport.com/methodology