HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator
FDA 510(k) K953582 · Varian Canada, Inc.
510(k) numberK953582
Submission
- Device name
- HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator
- Applicant
- Varian Canada, Inc.
Canada L7g 2j4, CA - Received
- August 1, 1995
- Decision date
- September 26, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator cleared by the FDA?
HFX350, 30KW, 300MA, 1 or 3 Phase Radiographic & Fluoroscopic X-Ray Generator (K953582) received a 510(k) decision of Substantially Equivalent on September 26, 1995, 56 days after the submission was received.
What is the product code of K953582?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.