Cleared Traditional

K023519 - RADIONICS VARILINK 2

K023519 is an FDA 510(k) clearance for RADIONICS VARILINK 2, manufactured by Radionics, A Division of Tyco Healthcare Group LP. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 87-day FDA review.

K023519 · Radionics, A Division of Tyco Healthcare Group LP · Radiology device
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Jan 2003
Decision
87d
Days
Class 2
Risk

K023519 is an FDA 510(k) clearance for the RADIONICS VARILINK 2. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Radionics, A Division of Tyco Healthcare Group LP (Burlington, US). The FDA issued a Cleared decision on January 16, 2003 after a review of 87 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Radionics, A Division of Tyco Healthcare Group LP devices

FDA 510(k) Submission Details - K023519

510(k) Number K023519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 2002
Decision Date January 16, 2003
Days to Decision 87 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
20d faster than avg
Panel avg: 107d · This submission: 87d
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 641
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K023519.
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