Submission Details
| 510(k) Number | K913425 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 1991 |
| Decision Date | November 24, 1992 |
| Days to Decision | 481 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
K913425 is an FDA 510(k) clearance for the DIAL-A-RAD PORTA RAD TABLE, a Table, Radiographic, Stationary Top (Class II — Special Controls, product code IXQ), submitted by Dial-A-Rad (Orlando, US). The FDA issued a Cleared decision on November 24, 1992, 481 days after receiving the submission on August 1, 1991. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K913425 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 01, 1991 |
| Decision Date | November 24, 1992 |
| Days to Decision | 481 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 |