The following data is part of a premarket notification filed by Ge Medical Systems Israel, Ultrasound, Ltd. with the FDA for Ge Vivid I Diagnostic Ultrasound, Ge Vivid Q Diagnostic Ultrasound.
| Device ID | K092140 |
| 510k Number | K092140 |
| Device Name: | GE VIVID I DIAGNOSTIC ULTRASOUND, GE VIVID Q DIAGNOSTIC ULTRASOUND |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Contact | James Turner |
| Correspondent | James Turner GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. 3000 N. GRANDVIEW BLVD. Waukesha, WI 53188 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-15 |
| Decision Date | 2009-08-21 |
| Summary: | summary |