K970640 is an FDA 510(k) clearance for the PHILIPS EASY DIAGNOST. This device is classified as a Table, Radiographic, Tilting (Class II - Special Controls, product code IXR).
Submitted by Philips Medical Systems North America, Inc. (Shelton, US). The FDA issued a Cleared decision on March 21, 1997, 29 days after receiving the submission on February 20, 1997.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K970640 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 1997 |
| Decision Date | March 21, 1997 |
| Days to Decision | 29 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 |