# K023112: Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9

- Pathway: 510(k) (Traditional)
- Applicant: Problem Solving Concepts, Inc.
- Decided: Dec 17, 2002 after 89 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 1 cites it directly.
0 of 3 devices 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) ProSolv Echo: named in the summary without a submission number

## Most influential descendants
- K041581: Compacs, Version 1.0 (2004), 1 descendant of its own
- K120514: Cardiopacs (2012), 0 descendants of its own

## Recalls of this device
- Feb 4, 2015 · Class II · Z-1612-2015: Under certain circumstances the patient Demographics in a report exported into the EMR may not match the demographics shown in the corresponding Synapse CV clinical report.
- Feb 4, 2015 · Class II · Z-1611-2015: Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

## Indications for use
ProSolv@ CardioVascular is intended for use by doctors and non-physicians (erg., sonographers, technicians, nurses) who are .affiliated with medical labs that use images obtained from digital-imaging DICOM instruments (echo, vascular, nuclear cardiology, cardiac catheterization, MRI, etc.) The ProSolv@Cardiovascular image management and reporting system is software that operates on standard PC equipment using Windows 95 or later operating system. ProSolv@CardioVascular provides the functionality for archiving, viewing, measuring, analyzing, and reporting digital studies generated by digital-imaging instruments from a multitude of manufacturers. The software is available in several configurations: Administrator (report viewing, edit patient demographic information), Viewer (image and report viewing, basic measurements), and Analyzer (Viewer features plus measuretnents, qualitative assessment, and report creation and design). The software can be used in a variety of network configurations ranging from a stand-alone workstation to a network of workstations connected through TCP/IP networking to a ProSolv@ DICOM Server. The DICOM Server permits studies to be transferred from DICOM compatible imaging instruments directly to a ProSolv@database using TCP/IP.

Source page: https://510kreport.com/device/K023112
Methodology: https://510kreport.com/methodology