K953402 is an FDA 510(k) clearance for the UNIVERSIX 190. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).
Submitted by Philips Medical Systems (Cleveland), Inc. (Cleveland, US). The FDA issued a Cleared decision on August 11, 1995, 22 days after receiving the submission on July 20, 1995.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.
| 510(k) Number | K953402 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 20, 1995 |
| Decision Date | August 11, 1995 |
| Days to Decision | 22 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXY — Holder, Radiographic Cassette, Wall-mounted |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1880 |