The following data is part of a premarket notification filed by Ultromics Ltd with the FDA for Echogo Core.
| Device ID | K191171 |
| 510k Number | K191171 |
| Device Name: | EchoGo Core |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Ultromics Ltd Stansfeld Park, Quarry Road Oxford, GB Ox3 8sb |
| Contact | Melissa Clark |
| Correspondent | Melissa Clark Ultromics Ltd Stansfeld Park, Quarry Road Oxford, GB Ox3 8sb |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-01 |
| Decision Date | 2019-11-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060634690003 | K191171 | 000 |