Digital Fluoricon Cardiac/Vascular Quantitative
FDA 510(k) K863132 · General Electric Co.
510(k) numberK863132
Submission
- Device name
- Digital Fluoricon Cardiac/Vascular Quantitative
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- August 15, 1986
- Decision date
- January 14, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Digital Fluoricon Cardiac/Vascular Quantitative cleared by the FDA?
Digital Fluoricon Cardiac/Vascular Quantitative (K863132) received a 510(k) decision of Substantially Equivalent on January 14, 1987, 152 days after the submission was received.
What is the product code of K863132?
The FDA product code is LLZ – System, Image Processing, Radiological, a Class II (moderate risk) device regulated under 21 CFR 892.2050.