K082485 is an FDA 510(k) clearance for the MODIFICATION TO SUPEROPEN 0.23T MRI SYSTEM, MODEL NAM-P023A. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Neusoft Medical Systems Co., Ltd. (Shenyang, Liaoning, CN). The FDA issued a Cleared decision on September 9, 2008, 12 days after receiving the submission on August 28, 2008.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K082485 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 28, 2008 |
| Decision Date | September 09, 2008 |
| Days to Decision | 12 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | LNH - System, Nuclear Magnetic Resonance Imaging |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1000 |