The following data is part of a premarket notification filed by Ge Medical System Israel Ltd. with the FDA for Vivid S5 Diagnostic Ultrasound System, Vivid S6 Diagnostic Ultrasound System.
| Device ID | K121063 |
| 510k Number | K121063 |
| Device Name: | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM, VIVID S6 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEM ISRAEL LTD. 9900 INNOVATION DR Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE MEDICAL SYSTEM ISRAEL LTD. 9900 INNOVATION DR Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| Subsequent Product Code | LLZ |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-06 |
| Decision Date | 2012-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682115766 | K121063 | 000 |
| 00840682115759 | K121063 | 000 |
| 00840682115599 | K121063 | 000 |
| 00840682110921 | K121063 | 000 |
| 00840682107174 | K121063 | 000 |
| 00840682107143 | K121063 | 000 |
| 00840682107129 | K121063 | 000 |
| 00840682107051 | K121063 | 000 |
| 00840682105262 | K121063 | 000 |