510(k) K230421
SOMATOM Edge Plus, SOMATOM Confidence, SOMATOM Definition Edge, SOMATOM Definition AS/AS+, SOMATOM Definition AS Open, SOMATOM Drive, SOMATOM Force, SOMATOM Definition Flash by
Siemens Medical Solutions USA, Inc.
— Product Code JAK
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 16, 2023
- Date Received
- February 16, 2023
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, X-Ray, Tomography, Computed
- Device Class
- Class II
- Regulation Number
- 892.1750
- Review Panel
- RA
- Submission Type