Cleared Traditional

K072079 - IGUIDE SYSTEM

K072079 is an FDA 510(k) clearance for IGUIDE SYSTEM, manufactured by Medical Intelligence Medizintechnik-GmbH-An Elekta. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K072079 · Medical Intelligence Medizintechnik-GmbH-An Elekta · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2007
Decision
15d
Days
Class 2
Risk

K072079 is an FDA 510(k) clearance for the IGUIDE SYSTEM. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Medical Intelligence Medizintechnik-GmbH-An Elekta (Schwabmunchen, DE). The FDA issued a Cleared decision on August 14, 2007 after a review of 15 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.

FDA 510(k) Submission Details - K072079

510(k) Number K072079 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2007
Decision Date August 14, 2007
Days to Decision 15 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 107d · This submission: 15d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv Sud America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - IYE Accelerator, Linear, Medical

All 723
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K072079.
MHI-TM2000 LINEAR ACCELERATOR SYSTEM
K072047 · Mitsubishi Heavy Industries, Ltd. · Aug 2007
MODIFICATION TO CYBERKNIFE ROBOTIC RADIOSURGERY SYSTEM
K071531 · Accuray Incorporated · Aug 2007
HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)
K071992 · Varian Medical Systems · Aug 2007
TRACKLEAF-10
K071701 · Direx Systems Corp. · Jul 2007
ONC SOLUTIONS MARKER, MODELS 001001 TO 001012 AND 001021 TO 001032
K071673 · Onc Solutions, Inc. · Jul 2007
BAT ULTRASOUND LOCALIZATION AND POSITIONING SYSTEM, VERSION 6
K070611 · Nomos Corp. · Jul 2007
K072079 · IGUIDE SYSTEM
Download PDF FDA Summary Medical Intelligence …