510(k) K113365
K113365 is an FDA 510(k) premarket notification submitted by Advanced Imaging Research Dba Sree Medical Systems for the device "INFANT ARRAY". The FDA issued a decision of Substantially Equivalent on March 29, 2012. The device falls under product code MOS (Coil, Magnetic Resonance, Specialty), a Class II device regulated under 21 CFR 892.1000. Advanced Imaging Research Dba Sree Medical Systems has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 29, 2012
- Date Received
- November 15, 2011
- Clearance Type
- Traditional
- 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