Cleared Traditional

K192405 - Image Guidance System for Radiotherapy

K192405 is the FDA 510(k) clearance for Image Guidance System for Radiotherapy by Jiangsu Rayer Medical Technology Co., Ltd.. It is a Class 2 Radiology device (product code IYE) cleared through the Traditional 510(k) pathway after a 241-day FDA review.

K192405 · Jiangsu Rayer Medical Technology Co., Ltd. · Radiology device
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May 2020
Decision
241d
Days
Class 2
Risk

K192405 is an FDA 510(k) clearance for the Image Guidance System for Radiotherapy. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Jiangsu Rayer Medical Technology Co., Ltd. (Wuxi, CN). The FDA issued a Cleared decision on May 1, 2020 after a review of 241 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 Jiangsu Rayer Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K192405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 03, 2019
Decision Date May 01, 2020
Days to Decision 241 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
134d slower than avg
Panel avg: 107d · This submission: 241d
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

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