The following data is part of a premarket notification filed by Ge Medical Systems Ultrasound And Primary Care Diagnostics, with the FDA for Echopac Software Only, Echopac Plug-in.
| Device ID | K220940 |
| 510k Number | K220940 |
| Device Name: | EchoPAC Software Only, EchoPAC Plug-in |
| Classification | Automated Radiological Image Processing Software |
| Applicant | GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Contact | Tracey Ortiz |
| Correspondent | Lee Bush GE Medical Systems Ultrasound And Primary Care Diagnostics, LLC 9900 W. Innovation Drive Wauwatosa, WI 53226 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-31 |
| Decision Date | 2022-07-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00195278504326 | K220940 | 000 |
| 00195278504302 | K220940 | 000 |