510(k) K092230
K092230 is an FDA 510(k) premarket notification submitted by Time Medical Limited for the device "MONA - ORTHOPEDIC MRI SYSTEM, MODEL TMS-200ORTH-01". The FDA issued a decision of Substantially Equivalent on Nov 25, 2009. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Time Medical Limited has 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Nov 25, 2009
- Date Received
- Jul 23, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- Yes
Device Classification
- Device Name
- System, Nuclear Magnetic Resonance Imaging
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type
- 510(k)