TCT-1 Treatment Couch
FDA 510(k) K834201 · Therados, Inc.
510(k) numberK834201
Submission
- Device name
- TCT-1 Treatment Couch
- Applicant
- Therados, Inc.
Walker, MI, US - Received
- December 5, 1983
- Decision date
- March 5, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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Questions and answers
When was TCT-1 Treatment Couch cleared by the FDA?
TCT-1 Treatment Couch (K834201) received a 510(k) decision of Substantially Equivalent on March 5, 1984, 91 days after the submission was received.
What is the product code of K834201?
The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.