The following data is part of a premarket notification filed by Oni Medical Systems, Inc. with the FDA for Msk Extreme Mr Scanner, Model Aa5000.
| Device ID | K080048 |
| 510k Number | K080048 |
| Device Name: | MSK EXTREME MR SCANNER, MODEL AA5000 |
| Classification | System, Nuclear Magnetic Resonance Imaging |
| Applicant | ONI MEDICAL SYSTEMS, INC. 301 BALLARDVALE ST. SUITE 4 Wilmington, MA 01887 |
| Contact | Mark Puopolo |
| Correspondent | Mark Puopolo ONI MEDICAL SYSTEMS, INC. 301 BALLARDVALE ST. SUITE 4 Wilmington, MA 01887 |
| Product Code | LNH |
| CFR Regulation Number | 892.1000 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-08 |
| Decision Date | 2008-02-06 |
| Summary: | summary |