K925169 is an FDA 510(k) clearance for the SHIMADZU RADIOGRAPJHIC STAND BR-100. This device is classified as a Changer, Radiographic Film/cassette (Class II - Special Controls, product code KPX).
Submitted by Shimadzu Medical Systems (Gardena, US). The FDA issued a Cleared decision on December 3, 1992, 51 days after receiving the submission on October 13, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1860.
| 510(k) Number | K925169 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 13, 1992 |
| Decision Date | December 03, 1992 |
| Days to Decision | 51 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 |