The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for Voluson Expert 22, Voluson Expert 20, Voluson Expert 18.
| Device ID | K220358 |
| 510k Number | K220358 |
| Device Name: | Voluson Expert 22, Voluson Expert 20, Voluson Expert 18 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 Innovation Dr. Wauwatosa, WI 53226 |
| Contact | Bryan Behn |
| Correspondent | Bryan Behn GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 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 | 2022-02-08 |
| Decision Date | 2022-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278347497 | K220358 | 000 |
| 00195278347480 | K220358 | 000 |
| 00195278347473 | K220358 | 000 |
| 00195278283375 | K220358 | 000 |