The following data is part of a premarket notification filed by Riverain Technologies, Inc. with the FDA for Clearread Xray Pneumothorax.
| Device ID | K213566 |
| 510k Number | K213566 |
| Device Name: | ClearRead Xray Pneumothorax |
| Classification | Radiological Computer-assisted Prioritization Software For Lesions |
| Applicant | Riverain Technologies, Inc. 3020 South Tech Blvd. Miamisburg, OH 45342 -4860 |
| Contact | Jonathan Jackson |
| Correspondent | Jonathan Jackson Riverain Technologies, Inc. 3020 South Tech Blvd. Miamisburg, OH 45342 -4860 |
| Product Code | QFM |
| CFR Regulation Number | 892.2080 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-09 |
| Decision Date | 2022-03-10 |