The following data is part of a premarket notification filed by Ge Medical Systems Israel, Ultrasound, Ltd. with the FDA for Vivid I And Vivid Q.
| Device ID | K082374 |
| 510k Number | K082374 |
| Device Name: | VIVID I AND VIVID Q |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE MEDICAL SYSTEMS ISRAEL, ULTRASOUND, LTD. HAETGAR STR. 4 Tirat Carmel, IL 39120 |
| Contact | Israel Citron |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| 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 | Yes |
| Combination Product | No |
| Date Received | 2008-08-18 |
| Decision Date | 2008-09-02 |
| Summary: | summary |