The following data is part of a premarket notification filed by Aurora Imaging Technology, Inc. with the FDA for Modification To: Aurora.
| Device ID | K052698 |
| 510k Number | K052698 |
| Device Name: | MODIFICATION TO: AURORA |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-09-28 |
| Decision Date | 2005-11-08 |
| Summary: | summary |