510(k) K193317
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 2019
- Date Received
- November 29, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- Cabinet, X-Ray System
- Device Class
- Class II
- Regulation Number
- 892.1680
- Review Panel
- RA
- Submission Type