Radio Therapy Treatment Chair

FDA 510(k) K150382 · Radiation Products Design, Inc.

Substantially Equivalent

510(k) numberK150382

Submission

Device name
Radio Therapy Treatment Chair
Applicant
Radiation Products Design, Inc.
Albertville, MN, US
Received
February 18, 2015
Decision date
September 16, 2015
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
IYE – Accelerator, Linear, Medical
Device class
Class II (moderate risk)
Regulation
21 CFR 892.5050
Specialty
Radiology

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Questions and answers

When was Radio Therapy Treatment Chair cleared by the FDA?

Radio Therapy Treatment Chair (K150382) received a 510(k) decision of Substantially Equivalent on September 16, 2015, 210 days after the submission was received.

What is the product code of K150382?

The FDA product code is IYE – Accelerator, Linear, Medical, a Class II (moderate risk) device regulated under 21 CFR 892.5050.