The following data is part of a premarket notification filed by Aurora Imaging Technology, Inc. with the FDA for Modification To Aurora Mri System.
| Device ID | K073425 |
| 510k Number | K073425 |
| Device Name: | MODIFICATION TO AURORA MRI SYSTEM |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AURORA IMAGING TECHNOLOGY, INC. 39 HIGH ST. North Andover, MA 01845 |
| Contact | Michael A Douglas |
| Correspondent | Michael A Douglas AURORA IMAGING TECHNOLOGY, INC. 39 HIGH ST. North Andover, MA 01845 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-12-03 |
| Decision Date | 2008-09-16 |
| Summary: | summary |