510(k) K202238
K202238 is an FDA 510(k) premarket notification submitted by Ge Healthcare (Tianjin) Company Limited for the device "SIGNA Artist". The FDA issued a decision of Substantially Equivalent on September 4, 2020. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare (Tianjin) Company Limited has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 4, 2020
- Date Received
- August 7, 2020
- Clearance Type
- Special
- 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