Cleared Traditional

K203387 - AlignRT Plus

K203387 is an FDA 510(k) clearance for AlignRT Plus, manufactured by Vision Rt, Ltd.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K203387 · Vision Rt, Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2021
Decision
106d
Days
Class 2
Risk

K203387 is an FDA 510(k) clearance for the AlignRT Plus. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Vision Rt, Ltd. (London, GB). The FDA issued a Cleared decision on March 4, 2021 after a review of 106 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 Vision Rt, Ltd. devices

FDA 510(k) Submission Details - K203387

510(k) Number K203387 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 18, 2020
Decision Date March 04, 2021
Days to Decision 106 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
1d faster than avg
Panel avg: 107d · This submission: 106d
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 528
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K203387.
C-Qual M™ Breastboard
K211001 · Medtec, Inc. Dba Civco Medical Solutions and Civco · May 2021
Klarity Bolus
K202747 · Klarity Medical & Equipment (GZ) Co., Ltd. · May 2021
Identify
K210835 · Varian Medical Systems, Inc. · Apr 2021
Mobius3D
K203669 · Varian Medical Systems, Inc. · Jan 2021
ClearRT Helical kVCT for the Radixact Treatment Delivery System
K202412 · Accuray Incorporated · Dec 2020
MOSAIQ Oncology Information System
K203172 · Elekta Solutions AB · Dec 2020