K003931 is an FDA 510(k) clearance for the VIVID 7 WITH SONOPAC, MODEL FB0008XX. This device is classified as a System, Imaging, Pulsed Doppler, Ultrasonic (Class II - Special Controls, product code IYN).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on January 18, 2001, 29 days after receiving the submission on December 20, 2000.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1550.
| 510(k) Number | K003931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 2000 |
| Decision Date | January 18, 2001 |
| Days to Decision | 29 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 |