K925598 is an FDA 510(k) clearance for the BUCKYMATIC AUTOMATIC CHEST FILM CHANGER. This device is classified as a Changer, Radiographic Film/cassette (Class II - Special Controls, product code KPX).
Submitted by Acoma Medical Imaging, Inc. (Wheeling, US). The FDA issued a Cleared decision on February 1, 1993, 88 days after receiving the submission on November 5, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1860.
| 510(k) Number | K925598 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 05, 1992 |
| Decision Date | February 01, 1993 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | KPX — Changer, Radiographic Film/cassette |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1860 |