510(k) K050132
K050132 is an FDA 510(k) premarket notification submitted by Innovative Magnetic Resonance Imaging Systems, Inc. for the device "NEURO II-S". The FDA issued a decision of Substantially Equivalent on February 15, 2005. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Innovative Magnetic Resonance Imaging Systems, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 15, 2005
- Date Received
- January 21, 2005
- 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