Senographe 600T and 600TS Senix HF
FDA 510(k) K881882 · General Electric Co.
510(k) numberK881882
Submission
- Device name
- Senographe 600T and 600TS Senix HF
- Applicant
- General Electric Co.
Milwaukee, WI, US - Received
- May 4, 1988
- Decision date
- May 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Senographe 600T and 600TS Senix HF cleared by the FDA?
Senographe 600T and 600TS Senix HF (K881882) received a 510(k) decision of Substantially Equivalent on May 25, 1988, 21 days after the submission was received.
What is the product code of K881882?
The FDA product code is IZH – System, X-Ray, Mammographic, a Class II (moderate risk) device regulated under 21 CFR 892.1710.