K854328 is an FDA 510(k) clearance for the MEDEX X-RAY TABLE. This device is classified as a Table, Radiologic (Class II - Special Controls, product code KXJ).
Submitted by Philips Medical Systems (Cleveland), Inc. (Highland Heights, US). The FDA issued a Cleared decision on January 28, 1986, 92 days after receiving the submission on October 28, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1980.
| 510(k) Number | K854328 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 28, 1985 |
| Decision Date | January 28, 1986 |
| Days to Decision | 92 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | KXJ — Table, Radiologic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1980 |