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 System.
| Device ID | K152567 |
| 510k Number | K152567 |
| Device Name: | Voluson E6, Voluson E8, Voluson E10 Diagnostic Ultrasound System |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Healthcare 3114 N. Grandview Blvd. Waukesha, WI 53188 |
| Contact | Ayesha Pergadia |
| Correspondent | Ayesha Pergadia GE Healthcare 3114 N. Grandview Blvd. Waukesha, WI 53188 |
| Product Code | IYN |
| Subsequent Product Code | ITX |
| Subsequent Product Code | IYO |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-09-09 |
| Decision Date | 2015-11-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00840682108676 | K152567 | 000 |
| 00840682118705 | K152567 | 000 |
| 00840682108485 | K152567 | 000 |
| 00840682105231 | K152567 | 000 |
| 00840682104913 | K152567 | 000 |
| 00840682104494 | K152567 | 000 |
| 00840682100144 | K152567 | 000 |
| 00840682100137 | K152567 | 000 |
| 00840682100120 | K152567 | 000 |