510(k) K123417
K123417 is an FDA 510(k) premarket notification submitted by Ge Hangwei Medical Systems Co., Ltd. for the device "BRIVO MR355, OPTIMA MR360". The FDA issued a decision of Substantially Equivalent on January 17, 2013. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Ge Hangwei Medical Systems Co., Ltd. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2013
- Date Received
- November 6, 2012
- 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