Cleared Traditional

K192405 - Image Guidance System for Radiotherapy

K192405 is an FDA 510(k) clearance for Image Guidance System for Radiotherapy, manufactured by Jiangsu Rayer Medical Technology Co., Ltd.. The device is a Class 2 Radiology device with 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

FDA 510(k) Submission Details - K192405

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.

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
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