K905855 is an FDA 510(k) clearance for the VPW2877E7 X RAY POWER SUPPLY. This device is classified as a Generator, High-voltage, X-ray, Diagnostic (Class I - General Controls, product code IZO).
Submitted by Varian Canada, Inc. (Canada L7g 2j4, CA). The FDA issued a Cleared decision on February 13, 1991, 54 days after receiving the submission on December 21, 1990.
This device falls under the Radiology FDA review panel. Regulated under 21 CFR 892.1700.
| 510(k) Number | K905855 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 21, 1990 |
| Decision Date | February 13, 1991 |
| Days to Decision | 54 days |
| Submission Type | Traditional |
| Review Panel | Radiology (RA) |
| Summary | — |
| Product Code | IZO — Generator, High-voltage, X-ray, Diagnostic |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 892.1700 |