K935397 is an FDA 510(k) clearance for the NUCLEAR ASSOCIATES KNIGHT SR., KNIGHT JR. AND SESAM PORTABLE RADIOGRAPHY CASSETTE HOLDERS. This device is classified as a Cassette, Radiographic Film (Class II - Special Controls, product code IXA).
Submitted by Victoreen, Inc. (Cleveland, US). The FDA issued a Cleared decision on December 15, 1993, 36 days after receiving the submission on November 9, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1850.
| 510(k) Number | K935397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 09, 1993 |
| Decision Date | December 15, 1993 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Statement |
| Product Code | IXA — Cassette, Radiographic Film |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1850 |