K161047 is an FDA 510(k) clearance for the LOGIQ P9 and LOGIQ P7. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Ge Healthcare (Wauwatosa, US). The FDA issued a Cleared decision on May 5, 2016, 22 days after receiving the submission on April 13, 2016.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K161047 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 13, 2016 |
| Decision Date | May 05, 2016 |
| Days to Decision | 22 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYN — System, Imaging, Pulsed Doppler, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1550 |