K926407 is an FDA 510(k) clearance for the MODEL COLE TAB-2 TABLE W/MODEL COLE SFD-2 SPOTFILM. This device is classified as a Table, Radiologic (Class II - Special Controls, product code KXJ).
Submitted by Nucletron-Oldelft Corp. (Urbanna, US). The FDA issued a Cleared decision on March 31, 1993, 100 days after receiving the submission on December 21, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K926407 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1992 |
| Decision Date | March 31, 1993 |
| Days to Decision | 100 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KXJ — Table, Radiologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |