The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound & Primary Care Diagnostics Llc with the FDA for Logiq V1/ Logiq V2.
| Device ID | K153037 |
| 510k Number | K153037 |
| Device Name: | LOGIQ V1/ LOGIQ V2 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W. INNOVATION DRIVE Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE MEDICAL SYSTEMS ULTRASOUND & PRIMARY CARE DIAGNOSTICS LLC 9900 W. INNOVATION DRIVE Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-19 |
| Decision Date | 2016-01-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682102940 | K153037 | 000 |
| 00840682102933 | K153037 | 000 |