HF1202H PowerPlus Portable X-ray Equipment
FDA 510(k) K153059 · Minxray, Inc.
510(k) numberK153059
Submission
- Device name
- HF1202H PowerPlus Portable X-ray Equipment
- Applicant
- Minxray, Inc.
Northbrook, IL, US - Received
- October 21, 2015
- Decision date
- February 2, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was HF1202H PowerPlus Portable X-ray Equipment cleared by the FDA?
HF1202H PowerPlus Portable X-ray Equipment (K153059) received a 510(k) decision of Substantially Equivalent on February 2, 2016, 104 days after the submission was received.
What is the product code of K153059?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.