K933240 is an FDA 510(k) clearance for the POLYDOROS IS. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by Siemens Medical Solutions USA, Inc. (Iselin, US). The FDA issued a Cleared decision on September 7, 1993, 67 days after receiving the submission on July 2, 1993.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K933240 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 02, 1993 |
| Decision Date | September 07, 1993 |
| Days to Decision | 67 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | Summary PDF |
| Product Code | IZO — Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |