Shimadzu Mobile X-Ray System MUX-100 Series
FDA 510(k) K001517 · Shimadzu Corp.
510(k) numberK001517
Submission
- Device name
- Shimadzu Mobile X-Ray System MUX-100 Series
- Applicant
- Shimadzu Corp.
Torrance, CA, US - Received
- May 16, 2000
- Decision date
- June 27, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Shimadzu Mobile X-Ray System MUX-100 Series cleared by the FDA?
Shimadzu Mobile X-Ray System MUX-100 Series (K001517) received a 510(k) decision of Substantially Equivalent on June 27, 2000, 42 days after the submission was received.
What is the product code of K001517?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.