K924459 is an FDA 510(k) clearance for the DIGISCAN 2. This device is classified as a System, Imaging, X-ray, Electrostatic (Class II - Special Controls, product code IXK).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on December 17, 1992, 106 days after receiving the submission on September 2, 1992.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1630.
| 510(k) Number | K924459 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 02, 1992 |
| Decision Date | December 17, 1992 |
| Days to Decision | 106 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IXK — System, Imaging, X-ray, Electrostatic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 892.1630 |