The following data is part of a premarket notification filed by Advanced Imaging Research, Inc. with the FDA for Infant Cardiac Array.
| Device ID | K083539 |
| 510k Number | K083539 |
| Device Name: | INFANT CARDIAC ARRAY |
| Classification | Coil, Magnetic Resonance, Specialty |
| Applicant | ADVANCED IMAGING RESEARCH, INC. 4700 LAKESIDE AVE. SUITE 400 Cleveland, OH 44114 |
| Contact | Ravi Srinivasan |
| Correspondent | Ravi Srinivasan ADVANCED IMAGING RESEARCH, INC. 4700 LAKESIDE AVE. SUITE 400 Cleveland, OH 44114 |
| Product Code | MOS |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-11-28 |
| Decision Date | 2009-04-03 |