510(k) K192426
K192426 is an FDA 510(k) premarket notification submitted by Ge Healthcare (Tianjin) Company Limited for the device "Signa Voyager, Signa Voyager Quantum". The FDA issued a decision of Substantially Equivalent on October 1, 2019. 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
- October 1, 2019
- Date Received
- September 5, 2019
- 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