Universal Patient Chair Uni 2000X

FDA 510(k) K855063 · Siemens Medical Solutions USA, Inc.

Substantially Equivalent

510(k) numberK855063

Submission

Device name
Universal Patient Chair Uni 2000X
Applicant
Siemens Medical Solutions USA, Inc.
Iselin, NJ, US
Received
December 18, 1985
Decision date
January 30, 1986
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JAI – Couch, Radiation Therapy, Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5770
Specialty
Radiology

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Questions and answers

When was Universal Patient Chair Uni 2000X cleared by the FDA?

Universal Patient Chair Uni 2000X (K855063) received a 510(k) decision of Substantially Equivalent on January 30, 1986, 43 days after the submission was received.

What is the product code of K855063?

The FDA product code is JAI – Couch, Radiation Therapy, Powered, a Class II (moderate risk) device regulated under 21 CFR 892.5770.