K924445 is an FDA 510(k) clearance for the BA-4 WALL BUCKY AND BA-42 TILTING WALL BUCKY. This device is classified as a Holder, Radiographic Cassette, Wall-mounted (Class I - General Controls, product code IXY).
Submitted by Control-X, Inc. (Columbus, US). The FDA issued a Cleared decision on February 19, 1993, 171 days after receiving the submission on September 1, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1880.
| 510(k) Number | K924445 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 01, 1992 |
| Decision Date | February 19, 1993 |
| Days to Decision | 171 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXY — Holder, Radiographic Cassette, Wall-mounted |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1880 |