Submission Details
| 510(k) Number | K965096 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1996 |
| Decision Date | January 27, 1997 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
K965096 is an FDA 510(k) clearance for the FLUOROVIEW SERIES FLUOROSCOPIC TABLES, a Table, Radiographic, Tilting (Class II — Special Controls, product code IXR), submitted by U.S. Imaging Tables, Inc. (Happauge, US). The FDA issued a Cleared decision on January 27, 1997, 38 days after receiving the submission on December 20, 1996. This device falls under the Radiology review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K965096 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | December 20, 1996 |
| Decision Date | January 27, 1997 |
| Days to Decision | 38 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 892.1980 |