510(k) K211846
K211846 is an FDA 510(k) premarket notification submitted by Ge Medical Systems, LLC for the device "Discovery MI Gen2". The FDA issued a decision of Substantially Equivalent on Aug 20, 2021. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. Ge Medical Systems, LLC has 328 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 20, 2021
- Date Received
- Jun 15, 2021
- 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)