The following data is part of a premarket notification filed by Aurora Imaging Technology, Inc. with the FDA for Aurora Magnetic Resonance Diagnostic Device.
| Device ID | K012154 |
| 510k Number | K012154 |
| Device Name: | AURORA MAGNETIC RESONANCE DIAGNOSTIC DEVICE |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AURORA IMAGING TECHNOLOGY, INC. 39 HIGH ST. North Andover, MA 01845 |
| Contact | James J Rogers |
| Correspondent | James J Rogers 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 | 2001-07-11 |
| Decision Date | 2001-09-19 |
| Summary: | summary |