The following data is part of a premarket notification filed by Ezra Ai Inc. with the FDA for Ezra Plexo Software.
| Device ID | K192969 |
| 510k Number | K192969 |
| Device Name: | Ezra Plexo Software |
| Classification | Automated Radiological Image Processing Software |
| Applicant | Ezra AI Inc. 79 Madison Ave., Ste 545 New York, NY 10016 |
| Contact | David Girard |
| Correspondent | David Girard Ezra AI Inc. 79 Madison Ave., Ste 545 New York, NY 10016 |
| Product Code | QIH |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-23 |
| Decision Date | 2020-07-10 |