510(k) Report

510(k) · Cleared

Recalled · Class II · 2015

Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9

K023112510(k) TraditionalCleared Dec 17, 200289-day reviewClass II21 CFR 870.1425Recalls 2

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Problem Solving Concepts, Inc. · DQK Computer, Diagnostic, Programmable

Cleared on Dec 17, 2002 after an 89-day review. The FDA summary names its predicate without a number. 2 later devices descend from it. It has been recalled 2 times.

Decided
Dec 17, 2002
Review
89 days
Class
Class II
Product code
DQK
Recalls
2
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2004: 1 descendant cleared2012: 1 descendant cleared200020052010201520202025
  1. This deviceK023112 Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9Problem Solving Concepts, Inc. · 2002
  2. Descendant · cites it directly · 1 of its ownK041581 Compacs, Version 1.0Intelligent Images Srl · 2004
  3. Descendant · 2 generations on · 0 of its ownK120514 CardiopacsLumedx · 2012

Most influential descendants

Showing 2 of 2 · See all
  • K041581Compacs, Version 1.0Intelligent Images Srl · 2004 · cites it directly1descendant
  • K120514CardiopacsLumedx · 2012 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K023112Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9Problem Solving Concepts, Inc.2002—
+1K041581Compacs, Version 1.0Intelligent Images Srl2004—
+2K120514CardiopacsLumedx2012—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
201210
FIG. 1 — Lineage of K023112, 2002–2012Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in DQK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new DQK device

  1. #1 K213682 HemoSphere Advanced Monitor, HemoSphere…score 26.6 · 28 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*—ProSolv Echo
Named without a submission number
—

What descends from it? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K041581Compacs, Version 1.0Intelligent Images Srl20041

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Feb 4, 2015Class IIZ-1612-2015Software in the Use EnvironmentUnder 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, 2015Class IIZ-1611-2015Software in the Use EnvironmentMeasurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K041581 (Intelligent Images Srl, 2004) has gone furthest, with 1 descendant of its own.

How does its category compare?

All DQK devices

DQK Computer, Diagnostic, Programmable: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · DQK

23so far in 2026, the most since 2007

2007: 132008: 42009: 122010: 92011: 122012: 72013: 132014: 92015: 72016: 152017: 72018: 142019: 152020: 162021: 162022: 192023: 212024: 132025: 222026 (partial year): 23
2007high 23 (2026) · low 4 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · DQK

95in 2025

2007: 83 days median2008: 70 days median2009: 93 days median2010: 64 days median2011: 69 days median2012: 74 days median2013: 68 days median2014: 90 days median2015: 125 days median2016: 190 days median2017: 146 days median2018: 150 days median2019: 113 days median2020: 123 days median2021: 132 days median2022: 136 days median2023: 133 days median2024: 100 days median2025: 95 days median2026 (partial year): 151 days median
2007high 190 (2016) · low 64 (2010)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · DQK

1in 2025

2007: 42008: 12009: 22010: 32011: 22012: 32013: 12014: 42015: 22017: 22018: 62019: 12020: 12021: 12022: 22023: 22024: 242025: 12026 (partial year): 2
2007high 24 (2024) · low 0 (2016)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · DQK

433in 2025

2007: 182008: 342009: 402010: 492011: 552012: 1292013: 1802014: 1152015: 1312016: 3402017: 2522018: 2612019: 2182020: 2152021: 3512022: 3192023: 3402024: 5572025: 433
2007high 557 (2024) · low 18 (2007)2025

MAUDE reports naming product code DQK, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071383418
2008470134
20091293240
2010964349
20111269255
20127743129
201313681180
20149904115
201571252131
2016151900340
201771462252
2018141506261
2019151131218
2020161231215
2021161321351
2022191362319
2023211332340
20241310024557
202522951433
2026231512—

What is it indicated for?

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.…

Read the full statement (163 words)

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.

Indications for use as stated in the FDA summary.

More from Problem Solving Concepts, Inc.

2 FDA decisions under this applicant name. See the company

  • K993750Prosolv Echoviewer, Prosolv Echoviewer SE, Prosolv Echoanalyzer, Prosolv Echoserv, Prosolv EchoProblem Solving Concepts, Inc. · 2000

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The DQK category page

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https://510kreport.com/device/K023112 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023112: Prosolv Cardivascular Viewer; Analyzer; Server; Version 2.5.9.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023112

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026