CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows
FDA 510(k) K982004 · General Electric Co.
510(k) numberK982004
Submission
- Device name
- CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- June 8, 1998
- Decision date
- August 18, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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| K072952 | GE EchopacLLZ · Special | 11/16/2007SE |
| K072797 | GE Logiq I Comapact Ultrasound, GE Logiq E Compact Ultrasound, GE Vivid E Compact…IYO · Special | 10/17/2007SE |
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Questions and answers
When was CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows cleared by the FDA?
CT Coronary Artery Calcification Scoring (Cacs) Option for Advantage Windows (K982004) received a 510(k) decision of Substantially Equivalent on August 18, 1998, 71 days after the submission was received.
What is the product code of K982004?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.