CT Perfusion 2
FDA 510(k) K010042 · General Electric Co.
510(k) numberK010042
Submission
- Device name
- CT Perfusion 2
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- January 5, 2001
- Decision date
- January 30, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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 Perfusion 2 cleared by the FDA?
CT Perfusion 2 (K010042) received a 510(k) decision of Substantially Equivalent on January 30, 2001, 25 days after the submission was received.
What is the product code of K010042?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.