The following data is part of a premarket notification filed by Ge Vingmed Ultrasound As with the FDA for Ge Vivid E9 Diagnostic Ultrasound Imaging System.
| Device ID | K120201 |
| 510k Number | K120201 |
| Device Name: | GE VIVID E9 DIAGNOSTIC ULTRASOUND IMAGING SYSTEM |
| Classification | System, Imaging, Pulsed Echo, Ultrasonic |
| Applicant | GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE VINGMED ULTRASOUND AS 9900 W INNOVATION DR., RP-2138 Wauwatosa, WI 53226 |
| Product Code | IYO |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYN |
| CFR Regulation Number | 892.1560 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-23 |
| Decision Date | 2012-04-19 |
| Summary: | summary |