Mobile X-Ray System
FDA 510(k) K955036 · Shimadzu Corp.
510(k) numberK955036
Submission
- Device name
- Mobile X-Ray System
- Applicant
- Shimadzu Corp.
Kyoto City 604 Japan, JP - Received
- November 3, 1995
- Decision date
- December 22, 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 Mobile X-Ray System cleared by the FDA?
Mobile X-Ray System (K955036) received a 510(k) decision of Substantially Equivalent on December 22, 1995, 49 days after the submission was received.
What is the product code of K955036?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.