K963851 is an FDA 510(k) clearance for the TILTING RADIOGRAPHIC TABLE (REMOTE). This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on January 23, 1997, 120 days after receiving the submission on September 25, 1996.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K963851 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 25, 1996 |
| Decision Date | January 23, 1997 |
| Days to Decision | 120 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXR — Table, Radiographic, Tilting |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |