The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Logiq S7 Expert.
| Device ID | K160182 |
| 510k Number | K160182 |
| Device Name: | LOGIQ S7 Expert |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Healthcare 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Healthcare 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 | 2016-01-27 |
| Decision Date | 2016-02-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682110679 | K160182 | 000 |
| 00840682110082 | K160182 | 000 |
| 00840682110044 | K160182 | 000 |
| 00840682109956 | K160182 | 000 |
| 00840682109895 | K160182 | 000 |
| 00840682108584 | K160182 | 000 |
| 00840682108430 | K160182 | 000 |
| 00840682107846 | K160182 | 000 |
| 00840682107716 | K160182 | 000 |
| 00840682106573 | K160182 | 000 |
| 00840682106511 | K160182 | 000 |
| 00840682110334 | K160182 | 000 |
| 00840682110372 | K160182 | 000 |
| 00840682117623 | K160182 | 000 |
| 00840682117432 | K160182 | 000 |
| 00840682116817 | K160182 | 000 |
| 00840682115735 | K160182 | 000 |
| 00840682115704 | K160182 | 000 |
| 00840682115612 | K160182 | 000 |
| 00840682112390 | K160182 | 000 |
| 00840682111263 | K160182 | 000 |
| 00840682110754 | K160182 | 000 |
| 00840682110655 | K160182 | 000 |
| 00840682105064 | K160182 | 000 |