510(k) K143345
K143345 is an FDA 510(k) premarket notification submitted by Ge Healthcare Japan Corporation for the device "SIGNA Pioneer". The FDA issued a decision of Substantially Equivalent on July 10, 2015. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Healthcare Japan Corporation has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 10, 2015
- Date Received
- November 21, 2014
- 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