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Vscan Extend

by GE Medical Systems Ultrasound and Primary Care Diagnostics, LLC 510(k)

Active United States

510(k) K161588

Regulatory status

as of 26 Oct 2026

Recall ongoing. 1 ongoing FDA recall. See recalls

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK161588 Date31 Aug 2016ClearedStatusActive

Coverage

1 jurisdiction

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

United States — FDA 510(k) Active

Recalls

8 recalls · 1 ongoing · FDA

    • Ongoing Z-1839-2019 FDA Class II initiated 21 May 2019

    Overestimation bias in automatically calculated ejection fraction (EF) values while using LVivo EF app on the Vscan Extend product.

  • 7 recalls, same reason

    • Terminated Z-0521-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0524-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0518-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0520-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0522-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0523-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)
    • Terminated Z-0519-2022 FDA Class II initiated 4 Nov 2021 via K161588, on the same 510(k)

    The firm identified that the Vscan Extend device will not power on because of depleted battery, due to the device not being turned off prior to battery removal or when being connected to a computer without AC power.

Recalls marked "via" name another device cleared under the same FDA submission as this one.

Specification

510(k)

510(k) Number
FDA Product Code
IYN
FDA applicant
GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC
Device Class
Class II
Regulation
21 CFR Part 892.1550
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

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