510(k) K002964
K002964 is an FDA 510(k) premarket notification submitted by Innovative Magnetic Resonance Imaging Systems, Inc. for the device "NEURO II". The FDA issued a decision of Substantially Equivalent on December 19, 2000. 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
- December 19, 2000
- Date Received
- September 22, 2000
- 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