510(k) K123522
K123522 is an FDA 510(k) premarket notification submitted by Ge Healthcare (Ge Medical Systems, LLC) for the device "OPTIMA MR450W". The FDA issued a decision of Substantially Equivalent on Mar 13, 2013. 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
- Mar 13, 2013
- Date Received
- Nov 15, 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
- 510(k)