The following data is part of a premarket notification filed by Dyad Medical, Inc with the FDA for Libby Echo:prio.
| Device ID | K220956 |
| 510k Number | K220956 |
| Device Name: | Libby Echo:Prio |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Dyad Medical, Inc 215 Brighton Avenue, Suite 203 Boston, MA 02134 |
| Contact | Ronny Shalev |
| Correspondent | Yervant Chijian Pharmalex Pty Ltd Suite 10.4, 1 Chandos Street St. Leonards, AU 2068 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-04-01 |
| Decision Date | 2022-07-20 |