The following data is part of a premarket notification filed by Ultromics Ltd with the FDA for Echogo Pro.
| Device ID | K201555 |
| 510k Number | K201555 |
| Device Name: | EchoGo Pro |
| Classification | Computer-assisted Diagnostic Software For Lesions Suspicious For Cancer |
| Applicant | Ultromics Ltd 4630 Kingsgate, Cascade Way, Oxford Business Park South Oxford, GB Ox4 2su |
| Contact | Melissa Clark |
| Correspondent | Melissa Clark Ultromics Ltd 4630 Kingsgate, Cascade Way, Oxford Business Park South Oxford, GB Ox4 2su |
| Product Code | POK |
| CFR Regulation Number | 892.2060 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-10 |
| Decision Date | 2020-12-18 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060634690010 | K201555 | 000 |