Cleared Traditional

OMNIPRO INCLINE (K092018) - FDA 510(k) Clearance

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

K092018 · Iba Dosimetry GmbH · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
74d
Days
Class 2
Risk

K092018 is an FDA 510(k) clearance for the OMNIPRO INCLINE. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Iba Dosimetry GmbH (Bartlett, US). The FDA issued a Cleared decision on September 18, 2009 after a review of 74 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 Iba Dosimetry GmbH devices

Submission Details

510(k) Number K092018 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 06, 2009
Decision Date September 18, 2009
Days to Decision 74 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
33d faster than avg
Panel avg: 107d · This submission: 74d
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 732
Devices cleared under the same product code (IYE) and FDA review panel - the closest regulatory comparables to K092018.
LUNA 3D
K253004 · Lap GmbH Laser Applikationen · Jun 2026
AerFrame Patient Immobilization System (AFPIS)
K260792 · Stabilix, LLC · May 2026
VERIQA RT EPID 3D
K252258 · Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · Apr 2026
ClearCheck (RADCC V2.7)
K253962 · Radformation, Inc. · Apr 2026
AlignRT Plus (8.0)
K253012 · Vision Rt, Ltd. · Mar 2026
Halcyon, Ethos Radiotherapy System (5.0)
K252977 · Varian Medical Systems, Inc. · Jan 2026