Maxiray 125 Tube Unit
FDA 510(k) K781524 · General Electric Co.
510(k) numberK781524
Submission
- Device name
- Maxiray 125 Tube Unit
- Applicant
- General Electric Co.
Mchenry, IL, US - Received
- September 5, 1978
- Decision date
- October 17, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Maxiray 125 Tube Unit cleared by the FDA?
Maxiray 125 Tube Unit (K781524) received a 510(k) decision of Substantially Equivalent on October 17, 1978, 42 days after the submission was received.
What is the product code of K781524?
The FDA product code is ITY – Assembly, Tube Housing, X-Ray, Diagnostic, a Class I (low risk) device regulated under 21 CFR 892.1760.