Portable X-Ray Unit, Models PXP-15/20/40HF
FDA 510(k) K032628 · United Radiology Systems, Inc.
510(k) numberK032628
Submission
- Device name
- Portable X-Ray Unit, Models PXP-15/20/40HF
- Applicant
- United Radiology Systems, Inc.
Deerfield, IL, US - Received
- August 26, 2003
- Decision date
- February 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Portable X-Ray Unit, Models PXP-15/20/40HF cleared by the FDA?
Portable X-Ray Unit, Models PXP-15/20/40HF (K032628) received a 510(k) decision of Substantially Equivalent on February 2, 2004, 160 days after the submission was received.
What is the product code of K032628?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.