510(k) K073297 ยท IYN System, Imaging, Pulsed Doppler, Ultrasonic
GE LOGIQ P6
| Applicant | General Electric Co., Wauwatosa WI, US |
| Decision | Substantially Equivalent, Dec 18, 2007 |
| Received | Nov 23, 2007 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K073297
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 30, 2019 | GE Healthcare, LLC GE HEALTHCARE LOGIQ P6 Premium TruScan(TM) Imagining Technology:
(a) Model BT09
(b) Model BT07
Product Usage: The device is intended for use by a qualified physician for ultrasound evaluation of Fetal Terminated |
IYN | None listed |
| Jan 21, 2012 | GE Healthcare, LLC GE LOGIQ P6 Ultrasound System.
The device is intended for use by a qualified physician for the evaluation of soft tissue and blood flow in the clinical applications of: Fetal; Abdominal; Pediatric; S Terminated |
IYN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.