510(k) K223425
K223425 is an FDA 510(k) premarket notification submitted by Mdai, Inc. for the device "MD.ai Viewer". The FDA issued a decision of Substantially Equivalent on Feb 10, 2023. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 10, 2023
- Date Received
- Nov 14, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Image Processing, Radiological
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
- 510(k)