510(k) K063342
K063342 is an FDA 510(k) premarket notification submitted by Medrad, Inc. for the device "MEDRAD ECOIL IMAGING SYSTEM FOR PHILIPS". The FDA issued a decision of Substantially Equivalent on November 30, 2006. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Medrad, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 30, 2006
- Date Received
- November 6, 2006
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coil, Magnetic Resonance, Specialty
- Device Class
- Class II
- Regulation Number
- 892.1000
- Review Panel
- RA
- Submission Type