The following data is part of a premarket notification filed by Ultromics Limited with the FDA for Echogo Core (2.0).
| Device ID | K213275 |
| 510k Number | K213275 |
| Device Name: | EchoGo Core (2.0) |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Ultromics Limited 4630 Kingsgate, Cascade Way Oxford Business Park South Oxford, GB Ox4 2su |
| Contact | Jaco Jacobs |
| Correspondent | Jaco Jacobs Ultromics Limited 4630 Kingsgate, Cascade Way Oxford Business Park South Oxford, GB Ox4 2su |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-30 |
| Decision Date | 2021-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060634690027 | K213275 | 000 |