Minxray, Models HFP24 and HFP40
FDA 510(k) K060566 · Mikasa X-Ray Co., Ltd.
510(k) numberK060566
Submission
- Device name
- Minxray, Models HFP24 and HFP40
- Applicant
- Mikasa X-Ray Co., Ltd.
Deer Field, IL, US - Received
- March 3, 2006
- Decision date
- April 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Minxray, Models HFP24 and HFP40 cleared by the FDA?
Minxray, Models HFP24 and HFP40 (K060566) received a 510(k) decision of Substantially Equivalent on April 5, 2006, 33 days after the submission was received.
What is the product code of K060566?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.