510(k) K080762
K080762 is an FDA 510(k) premarket notification submitted by Imaging Biometrics, LLC for the device "IB NEURO, VERSION 1.0". The FDA issued a decision of Substantially Equivalent on May 15, 2008. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Imaging Biometrics, LLC has 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 15, 2008
- Date Received
- Mar 18, 2008
- 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)