K951315 is an FDA 510(k) clearance for the CATHETERIZATION TABLE KS-60. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).
Submitted by Shimadzu Medical Systems (Torrance, US). The FDA issued a Cleared decision on May 11, 1995, 49 days after receiving the submission on March 23, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K951315 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 23, 1995 |
| Decision Date | May 11, 1995 |
| Days to Decision | 49 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IZZ — Table, Radiographic, Non-tilting, Powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |