K972704 is an FDA 510(k) clearance for the KINEMATIC POSITIONERS. This device is classified as a System, Nuclear Magnetic Resonance Imaging (Class II - Special Controls, product code LNH).
Submitted by Ge Medical Systems, Inc. (Milwaukee, US). The FDA issued a Cleared decision on September 29, 1997, 73 days after receiving the submission on July 18, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1000.
| 510(k) Number | K972704 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 18, 1997 |
| Decision Date | September 29, 1997 |
| Days to Decision | 73 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 |