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Heartsuite Hemodynamics 7.10

by Emageon, Inc.

510(k) K082421

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

11 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 NumberK082421 Date17 Dec 2008ClearedStatusActive

Recalls

11 recalls · FDA

    • Terminated Z-1457-2017 FDA Class II initiated 4 Apr 2016

    In some instances, the system will lock tabs within a study, even when a second user does not have the study open on a different workstation.

    • Terminated Z-1778-2017 FDA Class II initiated 4 Apr 2016

    Use of the software may show an incorrect value to the user when viewing the Fractional Flow Reserve (FFR) results during recording.

    • Terminated Z-1091-2017 FDA Class II initiated 28 Mar 2016

    There is a potential connection issue when powering up the Merge Hemo Record Station and the Hemo Monitor does not communicate with the Client PC.

    • Terminated Z-2707-2017 FDA Class II initiated 10 Mar 2016

    If the PDM is utilized to output a pressure for computing fractional flow reserve (FFR), the analog output may not reflect the true representation of the selected pressure waveform being provided by the PDM to the Link Assembly which provides the analog output.

    • Terminated Z-0554-2016 FDA Class II initiated 26 Oct 2015

    The firm, Merge Healthcare, sent out Merge HEMO V10.0 & Merge CARDIO V10.1 software to 3 customers before the product was completely validated in house.

    • Terminated Z-1203-2017 FDA Class II initiated 31 May 2015

    Non-invasive blood pressure pumps (NIBP) voltage is not sufficient and causes the NIBP pumps to fail prior to reaching adequate initial pressure.

    • Terminated Z-1923-2017 FDA Class II initiated 30 Mar 2015

    The units may display the alarm "sampling line clogged" after the flow zeroing procedure that is conducted automatically 1 hour after start up. This could result in the potential of a small bias added to the CO2 measurement and affect the alarm notification.

    • Terminated Z-2347-2015 FDA Class II initiated 21 Jan 2015

    A system freeze-up of the Merge Hemo system, that included the PHASEIN End Tidal CO2 unit, resulted in the user needing to move the patient to another cath lab.

    • Terminated Z-0143-2015 FDA Class II initiated 29 Sep 2014

    It has been reported that during use, the SpO2 value displayed on the Hemo Monitor may not update to reflect changes in the patient's oxygen value. It is also possible that if using the pulse rate of the SpO2 finger clip to calculate the patient's heart rate, it too may be subject to displaying a stale value.

    • Terminated Z-0665-2017 FDA Class II initiated 30 Apr 2014

    The application may crash during the cath lab procedure.

    • Terminated Z-2341-2016 FDA Class II initiated 2 Jul 2012

    The International Normalized Ratio (INR) value displayed in the study report does not match the value that is imported on the pre-procedure labs screen from HL7

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
Device Class
Class II
Regulation
21 CFR Part 870.1425
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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