Sytec Dentascan
FDA 510(k) K914305 · General Electric Co.
510(k) numberK914305
Submission
- Device name
- Sytec Dentascan
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- September 25, 1991
- Decision date
- February 27, 1992
- 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 Sytec Dentascan cleared by the FDA?
Sytec Dentascan (K914305) received a 510(k) decision of Substantially Equivalent on February 27, 1992, 155 days after the submission was received.
What is the product code of K914305?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.