Ct/T 9800
FDA 510(k) K812241 · General Electric Co.
510(k) numberK812241
Submission
- Device name
- Ct/T 9800
- Applicant
- General Electric Co.
Walker, MI, US - Received
- August 11, 1981
- Decision date
- September 9, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253836 | FCT iStream Phase 2JAK · Traditional | Fujifilm Corporation | 09/04/2026SE |
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| K253026 | Respiratory Gating for Scanners (2.1)JAK · Traditional | Varian Medical Systems, Inc. | 06/04/2026SE |
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| K082317 | GE Lunar Frax 10-YEAR Fracture Risk Software OptionKGI · Traditional | 09/26/2008SE |
| K081921 | GE Vivid E9 UltrasoundIYN · Special | 08/06/2008SE |
| K073297 | GE Logiq P6IYN · Special | 12/18/2007SE |
| 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 |
| K072075 | Modification to GE Logiq A3IYN · Special | 08/29/2007SE |
| K071985 | GE Vivid S5 and S6 Diagnostic UltrasoundIYN · Special | 08/17/2007SE |
Questions and answers
When was Ct/T 9800 cleared by the FDA?
Ct/T 9800 (K812241) received a 510(k) decision of Substantially Equivalent on September 9, 1981, 29 days after the submission was received.
What is the product code of K812241?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.