Cleared Traditional

K202412 - ClearRT Helical kVCT for the Radixact T...

K202412 is the FDA 510(k) clearance for ClearRT Helical kVCT for the Radixact T... by Accuray Incorporated. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 116-day FDA review.

K202412 · Accuray Incorporated · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2020
Decision
116d
Days
Class 2
Risk

K202412 is an FDA 510(k) clearance for the ClearRT Helical kVCT for the Radixact Treatment Delivery System. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Accuray Incorporated (Madison, US). The FDA issued a Cleared decision on December 18, 2020 after a review of 116 days - within the typical 510(k) review window.

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 Accuray Incorporated devices

Submission Details

510(k) Number K202412 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2020
Decision Date December 18, 2020
Days to Decision 116 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
9d slower than avg
Panel avg: 107d · This submission: 116d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 315
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K202412.
Identify
K210835 · Varian Medical Systems, Inc. · Apr 2021
AlignRT Plus
K203387 · Vision Rt, Ltd. · Mar 2021
Mobius3D
K203669 · Varian Medical Systems, Inc. · Jan 2021
MOSAIQ Oncology Information System
K203172 · Elekta Solutions AB · Dec 2020
BeamSite
K200940 · Doseoptics, LLC · Dec 2020
ExacTrac Dynamic
K203173 · Brainlab AG · Nov 2020