510(k) K212004
K212004 is an FDA 510(k) premarket notification submitted by GE Healthcare for the device "MyoSPECT, MyoSpect ES". The FDA issued a decision of Substantially Equivalent on August 27, 2021. The device falls under product code KPS (System, Tomography, Computed, Emission), a Class II device regulated under 21 CFR 892.1200. GE Healthcare has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 27, 2021
- Date Received
- June 28, 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