510(k) K071154
K071154 is an FDA 510(k) premarket notification submitted by Neusoft Medical Systems Co., Ltd. for the device "SUPERSTAR 0.35T MRI SYSTEM". The FDA issued a decision of Substantially Equivalent on May 10, 2007. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Neusoft Medical Systems Co., Ltd. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 10, 2007
- Date Received
- April 25, 2007
- 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