Model SR-115 Portable X-Ray System
FDA 510(k) K052001 · Source-Ray, Inc.
510(k) numberK052001
Submission
- Device name
- Model SR-115 Portable X-Ray System
- Applicant
- Source-Ray, Inc.
Bohemia, NY, US - Received
- July 25, 2005
- Decision date
- August 11, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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Questions and answers
When was Model SR-115 Portable X-Ray System cleared by the FDA?
Model SR-115 Portable X-Ray System (K052001) received a 510(k) decision of Substantially Equivalent on August 11, 2005, 17 days after the submission was received.
What is the product code of K052001?
The FDA product code is IZL – System, X-Ray, Mobile, a Class II (moderate risk) device regulated under 21 CFR 892.1720.