K952701 is an FDA 510(k) clearance for the MED-TRON SPECT IMAGING TABLE. This device is classified as a Table, Radiographic, Non-tilting, Powered (Class II - Special Controls, product code IZZ).
Submitted by Med-Tron Products, Inc. (Port Jefferson Sta., US). The FDA issued a Cleared decision on July 6, 1995, 23 days after receiving the submission on June 13, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K952701 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 13, 1995 |
| Decision Date | July 06, 1995 |
| Days to Decision | 23 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 |