The following data is part of a premarket notification filed by Advanced Imaging Research Dba Sree Medical Systems with the FDA for Infant Array.
| Device ID | K113365 |
| 510k Number | K113365 |
| Device Name: | INFANT ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland, OH 44103 |
| Contact | Ravi Sprinivasan |
| Correspondent | Ravi Sprinivasan ADVANCED IMAGING RESEARCH DBA SREE MEDICAL SYSTEMS PO BOX 603220 Cleveland, OH 44103 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-11-15 |
| Decision Date | 2012-03-29 |
| Summary: | summary |