510(k) K221136
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2022
- Date Received
- April 19, 2022
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Display, Diagnostic Radiology
- Device Class
- Class II
- Regulation Number
- 892.2050
- Review Panel
- RA
- Submission Type
The device is intended for use in displaying radiological images for review, analysis, and diagnosis by trained medical practitioners.