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PROSOLV CARDIVASCULAR VIEWER - Version 2.5.9

by Problem Solving Concepts, Inc.

510(k) K023112

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK023112 Date17 Dec 2002ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-1612-2015 FDA Class II initiated 4 Feb 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.

    • Terminated Z-1611-2015 FDA Class II initiated 4 Feb 2015

    Measurement values in the EMR may not accurately reflect the actual measurement value on the Synapse Cardiovascular clinical report.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
DQK
Models / Variants
Version 2.5.9
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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