Cleared Traditional

K143485 - iGuide 2.1

K143485 is an FDA 510(k) clearance for iGuide 2.1, manufactured by Medical Intelligence Medizintechnik GmbH. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K143485 · Medical Intelligence Medizintechnik GmbH · Radiology device
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Mar 2015
Decision
86d
Days
Class 2
Risk

K143485 is an FDA 510(k) clearance for the iGuide 2.1. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medical Intelligence Medizintechnik GmbH (Schwabmuenchen, DE). The FDA issued a Cleared decision on March 4, 2015 after a review of 86 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 Medical Intelligence Medizintechnik GmbH devices

FDA 510(k) Submission Details - K143485

510(k) Number K143485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 2014
Decision Date March 04, 2015
Days to Decision 86 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 107d · This submission: 86d
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

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