Cleared Traditional

K150382 - Radio Therapy Treatment Chair

K150382 is an FDA 510(k) clearance for Radio Therapy Treatment Chair, manufactured by Radiation Products Design, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K150382 · Radiation Products Design, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2015
Decision
210d
Days
Class 2
Risk

K150382 is an FDA 510(k) clearance for the Radio Therapy Treatment Chair. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Radiation Products Design, Inc. (Albertville, US). The FDA issued a Cleared decision on September 16, 2015 after a review of 210 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Radiation Products Design, Inc. devices

FDA 510(k) Submission Details - K150382

510(k) Number K150382 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 18, 2015
Decision Date September 16, 2015
Days to Decision 210 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 107d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

IYE Device Classification - Class 2, Special Controls

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 560
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K150382.
Varian Treatment (VTx)
K151882 · Varian Medical Systems, Inc. · Oct 2015
MHI-TM2000 Linear Accelerator System, VERO, Imavis
K152867 · Mitsubishi Heavy Industries, Ltd. · Oct 2015
CygneX I System
K143560 · Accuthera, Inc. · Oct 2015
Model 206 Electrometer/Dosimeter
K150265 · Cnmc Company Incorporated · Sep 2015
ScandiDos Delta4 Phantom+
K151180 · Scandidos AB · Aug 2015
EDOSE
K150767 · Guangzhou Raydose Software Technology., LLC · Aug 2015