The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for Logiq E9, Logiq E9 Xdclear 2.0.
| Device ID | K163077 |
| 510k Number | K163077 |
| Device Name: | LOGIQ E9, LOGIQ E9 XDClear 2.0 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Medical Systems Ultrasound And Primary Care Diagnostics, 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-03 |
| Decision Date | 2016-11-17 |
| Summary: | summary |