K850125 is an FDA 510(k) clearance for the MULTI-SIZE CASSETTE HOLDER. 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. (Highland Heights, US). The FDA issued a Cleared decision on March 26, 1985, 71 days after receiving the submission on January 14, 1985.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.
| 510(k) Number | K850125 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 14, 1985 |
| Decision Date | March 26, 1985 |
| Days to Decision | 71 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IXY — Holder, Radiographic Cassette, Wall-mounted |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1880 |