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 | K152309 |
| 510k Number | K152309 |
| 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 | 2015-08-14 |
| Decision Date | 2015-09-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682110747 | K152309 | 000 |
| 00840682102407 | K152309 | 000 |
| 00840682102414 | K152309 | 000 |
| 00840682102421 | K152309 | 000 |
| 00840682104883 | K152309 | 000 |
| 00840682104906 | K152309 | 000 |
| 00840682104951 | K152309 | 000 |
| 00840682105040 | K152309 | 000 |
| 00840682107860 | K152309 | 000 |
| 00840682110631 | K152309 | 000 |
| 00840682110716 | K152309 | 000 |
| 00840682110877 | K152309 | 000 |
| 00840682109994 | K152309 | 000 |
| 00840682102377 | K152309 | 000 |