Shimadzu UD150L-R X-Ray High Voltage Generator
FDA 510(k) K934967 · Shimadzu Corp.
510(k) numberK934967
Submission
- Device name
- Shimadzu UD150L-R X-Ray High Voltage Generator
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- October 15, 1993
- Decision date
- December 13, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Shimadzu UD150L-R X-Ray High Voltage Generator cleared by the FDA?
Shimadzu UD150L-R X-Ray High Voltage Generator (K934967) received a 510(k) decision of Substantially Equivalent on December 13, 1993, 59 days after the submission was received.
What is the product code of K934967?
The FDA product code is IZO – Generator, High-Voltage, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1700.