K092140 is an FDA 510(k) clearance for the GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND. This device is classified as a System, Imaging, Pulsed Echo, Ultrasonic (Class II - Special Controls, product code IYO).
Submitted by Ge Medical Systems Israel, Ultrasound, Ltd. (Waukesha, US). The FDA issued a Cleared decision on August 21, 2009, 37 days after receiving the submission on July 15, 2009.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1560.
| 510(k) Number | K092140 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 15, 2009 |
| Decision Date | August 21, 2009 |
| Days to Decision | 37 days |
| Submission Type | Special |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IYO - System, Imaging, Pulsed Echo, Ultrasonic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1560 |