CT Scanner Diagnostic Console, Remote
FDA 510(k) K772198 · Varian Assoc., Inc.
510(k) numberK772198
Submission
- Device name
- CT Scanner Diagnostic Console, Remote
- Applicant
- Varian Assoc., Inc.
Mchenry, IL, US - Received
- November 29, 1977
- Decision date
- December 5, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was CT Scanner Diagnostic Console, Remote cleared by the FDA?
CT Scanner Diagnostic Console, Remote (K772198) received a 510(k) decision of Substantially Equivalent on December 5, 1977, 6 days after the submission was received.
What is the product code of K772198?
The FDA product code is JAK – System, X-Ray, Tomography, Computed, a Class II (moderate risk) device regulated under 21 CFR 892.1750.