Digital Fluorographic X-Ray System
FDA 510(k) K833530 · General Electric Co.
510(k) numberK833530
Submission
- Device name
- Digital Fluorographic X-Ray System
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- September 23, 1983
- Decision date
- November 21, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Digital Fluorographic X-Ray System cleared by the FDA?
Digital Fluorographic X-Ray System (K833530) received a 510(k) decision of Substantially Equivalent on November 21, 1983, 59 days after the submission was received.
What is the product code of K833530?
The FDA product code is JAA – System, X-Ray, Fluoroscopic, Image-Intensified, a Class II (moderate risk) device regulated under 21 CFR 892.1650.