Iirad Directray Operator Console
FDA 510(k) K980970 · Sterling Diagnostic Imaging, Inc.
510(k) numberK980970
Submission
- Device name
- Iirad Directray Operator Console
- Applicant
- Sterling Diagnostic Imaging, Inc.
Greenville, SC, US - Received
- March 16, 1998
- Decision date
- June 8, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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Questions and answers
When was Iirad Directray Operator Console cleared by the FDA?
Iirad Directray Operator Console (K980970) received a 510(k) decision of Substantially Equivalent on June 8, 1998, 84 days after the submission was received.
What is the product code of K980970?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.