510(k) K101768
K101768 is an FDA 510(k) premarket notification submitted by Miegmbh for the device "MIE SCINTRON GAMMA CAMERA SYSTEMS". The FDA issued a decision of Substantially Equivalent on Oct 5, 2010. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Miegmbh has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Oct 5, 2010
- Date Received
- Jun 23, 2010
- 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)