510(k) K941025
K941025 is an FDA 510(k) premarket notification submitted by Medical Advances, Inc. for the device "PHASED ARRAY BREAST COIL". The FDA issued a decision of Substantially Equivalent on Jun 8, 1994. The device falls under product code LNH (System, Nuclear Magnetic Resonance Imaging), a Class II device regulated under 21 CFR 892.1000. Medical Advances, Inc. has 56 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 8, 1994
- Date Received
- Mar 4, 1994
- 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)