510(k) K161588 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
Vscan Extend
| Applicant | GE Medical Systems Ultrasound & Primary Care Diagnostics, LLC, Wauwatosa WI, US |
| Decision | Substantially Equivalent, Aug 31, 2016 |
| Received | Jun 8, 2016 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K161588
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Console" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual DICOM" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual USB" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Dual Wi-Fi" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector DICOM" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector USB" Terminated |
IYO | None listed |
| Jan 24, 2022 | GE Healthcare, LLC GE Vscan Extend, being sold as "Vscan Extend Sector Wi-Fi" Terminated |
IYO | None listed |
| May 21, 2019 | GE Healthcare, LLC LVivo EF app on Vscan Extend. Sold under the following product names:
a. Vscan Extend Dual DICOM, Model Numbers H41212ZA, H41212RN;
b .Vscan Extend Dual USB, Model Number H41212RK;
c. Vscan Open, Classified |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.