510(k) K202392
K202392 is an FDA 510(k) premarket notification submitted by Sirtex Medical US Holdings, Inc. for the device "SIR-Spheres Microspheres Activity Calculator (SMAC)". The FDA issued a decision of Substantially Equivalent on Oct 23, 2020. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 23, 2020
- Date Received
- Aug 21, 2020
- 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)