K940696 is an FDA 510(k) clearance for the SYNCRA TILT OPTION FOR ANGIO DIAGNOST 5. This device is classified as a Table, Radiologic (Class II - Special Controls, product code KXJ).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on March 16, 1994, 28 days after receiving the submission on February 16, 1994.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K940696 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 16, 1994 |
| Decision Date | March 16, 1994 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | KXJ — Table, Radiologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |