Optiplanimat
FDA 510(k) K781531 · Siemens Corp.
510(k) numberK781531
Submission
- Device name
- Optiplanimat
- Applicant
- Siemens Corp.
Mchenry, IL, US - Received
- September 6, 1978
- Decision date
- September 14, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was Optiplanimat cleared by the FDA?
Optiplanimat (K781531) received a 510(k) decision of Substantially Equivalent on September 14, 1978, 8 days after the submission was received.
What is the product code of K781531?
The FDA product code is IZF – System, X-Ray, Tomographic, a Class II (moderate risk) device regulated under 21 CFR 892.1740.