510(k) K213668
K213668 is an FDA 510(k) premarket notification submitted by Ge Healthcare (Ge Medical Systems, LLC) for the device "SIGNA Hero". The FDA issued a decision of Substantially Equivalent on Jan 20, 2022. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare (Ge Medical Systems, LLC) has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 20, 2022
- Date Received
- Nov 22, 2021
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)