The following data is part of a premarket notification filed by Ge Healthcare with the FDA for Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems.
| Device ID | K142472 |
| 510k Number | K142472 |
| Device Name: | Voluson E6 / Voluson E8 / Voluson E10 Diagnostic Ultrasound Systems |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Healthcare 9900 W Innovation Dr Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Tracey Ortiz GE Healthcare 9900 W Innovation Dr 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 | 2014-09-03 |
| Decision Date | 2015-02-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682118217 | K142472 | 000 |
| 00840682118071 | K142472 | 000 |
| 00840682117999 | K142472 | 000 |
| 00840682117982 | K142472 | 000 |