510(k) K201034
K201034 is an FDA 510(k) premarket notification submitted by Siemens Medical Solutions USA, Inc. for the device "Syngo.CT CaScoring". The FDA issued a decision of Substantially Equivalent on May 14, 2020. The device falls under product code JAK (System, X-Ray, Tomography, Computed), a Class II device regulated under 21 CFR 892.1750. Siemens Medical Solutions USA, Inc. has 783 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 14, 2020
- Date Received
- Apr 20, 2020
- Clearance Type
- Special
- 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
- 510(k)