Standard Imaging Imsure Brachy Qa Software, Model 91331
FDA 510(k) K082773 · Standard Imaging, Inc.
510(k) numberK082773
Submission
- Device name
- Standard Imaging Imsure Brachy Qa Software, Model 91331
- Applicant
- Standard Imaging, Inc.
Middleton, WI, US - Received
- September 22, 2008
- Decision date
- November 19, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Standard Imaging Imsure Brachy Qa Software, Model 91331 cleared by the FDA?
Standard Imaging Imsure Brachy Qa Software, Model 91331 (K082773) received a 510(k) decision of Substantially Equivalent on November 19, 2008, 58 days after the submission was received.
What is the product code of K082773?
The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.