K912135 is an FDA 510(k) clearance for the XY IMAGING TABLE. This device is classified as a Bed, Scanning, Nuclear (Class I - General Controls, product code IYZ).
Submitted by Med-Tron Products, Inc. (Miller Place, US). The FDA issued a Cleared decision on July 17, 1991, 64 days after receiving the submission on May 14, 1991.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1350.
| 510(k) Number | K912135 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 14, 1991 |
| Decision Date | July 17, 1991 |
| Days to Decision | 64 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IYZ — Bed, Scanning, Nuclear |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1350 |