The following data is part of a premarket notification filed by Eko.ai Pte. Ltd. D/b/a Us2.ai with the FDA for Us2.v1.
| Device ID | K210791 |
| 510k Number | K210791 |
| Device Name: | Us2.v1 |
| Classification | Automated Radiological Image Processing Software |
| Applicant | eko.ai Pte. Ltd. D/b/a Us2.ai 2 College Road, #02-00 Singapore, SG 94080 |
| Contact | James Hare |
| Correspondent | Jared Seehafer Enzyme Corporation 611 Gateway Blvd Ste 120 South San Francisco, CA 94080 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-16 |
| Decision Date | 2021-07-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860005876808 | K210791 | 000 |