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 Diagnosticultrasound System.
| Device ID | K102393 |
| 510k Number | K102393 |
| Device Name: | VIVID S5 DIAGNOSTIC ULTRASOUND SYSTEM; VIVID S6 DIAGNOSTICULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Echo, 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 | 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 | 2010-08-23 |
| Decision Date | 2010-11-05 |
| Summary: | summary |