510(k) K193178
K193178 is an FDA 510(k) premarket notification submitted by Siemens Medical Solution USA, Inc. for the device "Biograph Horizon". The FDA issued a decision of Substantially Equivalent on Feb 12, 2020. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Siemens Medical Solution USA, Inc. has 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 12, 2020
- Date Received
- Nov 18, 2019
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Tomography, Computed, Emission
- Device Class
- Class II
- Regulation Number
- 892.1200
- Review Panel
- RA
- Submission Type
- 510(k)