Portable X-Ray System, Model Powermax 1260
FDA 510(k) K090655 · Source-Ray, Inc.
510(k) numberK090655
Submission
- Device name
- Portable X-Ray System, Model Powermax 1260
- Applicant
- Source-Ray, Inc.
Bohemia, NY, US - Received
- March 11, 2009
- Decision date
- July 14, 2009
- 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 System, Model Powermax 1260 cleared by the FDA?
Portable X-Ray System, Model Powermax 1260 (K090655) received a 510(k) decision of Substantially Equivalent on July 14, 2009, 125 days after the submission was received.
What is the product code of K090655?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.