The following data is part of a premarket notification filed by Aurora Imaging Technology, Inc. with the FDA for Modification To: Aurora.
| Device ID | K032678 |
| 510k Number | K032678 |
| Device Name: | MODIFICATION TO: AURORA |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | AURORA IMAGING TECHNOLOGY, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Contact | James R Veale |
| Correspondent | James R Veale AURORA IMAGING TECHNOLOGY, INC. 49 PLAIN STREET North Attleboro, MA 02760 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-08-29 |
| Decision Date | 2003-09-24 |
| Summary: | summary |