Submission Details
| 510(k) Number | K960083 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 1996 |
| Decision Date | July 24, 1996 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
K960083 is an FDA 510(k) clearance for the MOVABLE CANTILEVERED RADIOGRAPHIC TABLE XRT 100, 200 & 300, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on July 24, 1996, 195 days after receiving the submission on January 11, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K960083 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 11, 1996 |
| Decision Date | July 24, 1996 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXQ — Table, Radiographic, Stationary Top |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1980 |