510(k) K191582
K191582 is an FDA 510(k) premarket notification submitted by Canon Medical Systems Corporation for the device "Cartesion Prime". The FDA issued a decision of Substantially Equivalent on Aug 13, 2019. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Canon Medical Systems Corporation has 96 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 13, 2019
- Date Received
- Jun 14, 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)