Cleared Traditional

K190978 - RefleXion Medical Radiotherapy System

K190978 is an FDA 510(k) clearance for RefleXion Medical Radiotherapy System, manufactured by Reflexion Medical, Inc.. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 332-day FDA review.

K190978 · Reflexion Medical, Inc. · Radiology device
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Mar 2020
Decision
332d
Days
Class 2
Risk

K190978 is an FDA 510(k) clearance for the RefleXion Medical Radiotherapy System. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Reflexion Medical, Inc. (Hayward, US). The FDA issued a Cleared decision on March 12, 2020 after a review of 332 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Reflexion Medical, Inc. devices

FDA 510(k) Submission Details - K190978

510(k) Number K190978 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2019
Decision Date March 12, 2020
Days to Decision 332 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
225d slower than avg
Panel avg: 107d · This submission: 332d
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 333
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