510(k) K213566
K213566 is an FDA 510(k) premarket notification submitted by Riverain Technologies, Inc. for the device "ClearRead Xray Pneumothorax". The FDA issued a decision of Substantially Equivalent on March 10, 2022. The device falls under product code QFM (Radiological Computer-Assisted Prioritization Software For Lesions), a Class II device regulated under 21 CFR 892.2080. Riverain Technologies, Inc. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 10, 2022
- Date Received
- November 9, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Radiological Computer-Assisted Prioritization Software For Lesions
- Device Class
- Class II
- Regulation Number
- 892.2080
- Review Panel
- RA
- Submission Type
Radiological computer-assisted prioritization software for lesions is an image processing device intended to aid in prioritization and triage of time sensitive patient detection and diagnosis based on the analysis of medical images acquired from radiological signal acquisition systems. The device identifies or prioritizes time sensitive imaging for review by prespecified clinical users based on software-based image analysis but does not provide information from the image analysis other than triage and notification.