Cleared Traditional

RefleXion Medical Radiotherapy System (K190978) - FDA 510(k) Clearance

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

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 227
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