K071154 is an FDA 510(k) clearance for the SUPERSTAR 0.35T MRI SYSTEM. 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 May 10, 2007, 15 days after receiving the submission on April 25, 2007.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K071154 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 25, 2007 |
| Decision Date | May 10, 2007 |
| Days to Decision | 15 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 |