The following data is part of a premarket notification filed by Ge Medical Systems Israel Ltd. with the FDA for Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System.
| Device ID | K142323 |
| 510k Number | K142323 |
| Device Name: | Vivid S60 Diagnostic Ultrasound System, Vivid S70 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ISRAEL LTD. 4 Etgar Street Tirat Carmel, IL 39120 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Healthcare 9900 Innovation Drive Wauwatosa, WI 53226 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-20 |
| Decision Date | 2014-10-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682120128 | K142323 | 000 |
| 00840682115650 | K142323 | 000 |
| 00840682115582 | K142323 | 000 |
| 00840682111966 | K142323 | 000 |
| 00840682110976 | K142323 | 000 |
| 00840682105316 | K142323 | 000 |