PXS-810, Podiatry X-Ray System
FDA 510(k) K071392 · Source-Ray, Inc.
510(k) numberK071392
Submission
- Device name
- PXS-810, Podiatry X-Ray System
- Applicant
- Source-Ray, Inc.
Bohemia, NY, US - Received
- May 18, 2007
- Decision date
- August 3, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was PXS-810, Podiatry X-Ray System cleared by the FDA?
PXS-810, Podiatry X-Ray System (K071392) received a 510(k) decision of Substantially Equivalent on August 3, 2007, 77 days after the submission was received.
What is the product code of K071392?
The FDA product code is KPR – System, X-Ray, Stationary, a Class II (moderate risk) device regulated under 21 CFR 892.1680.