Cleared Traditional

K031634 - OMNIPRO I'MRT

K031634 is an FDA 510(k) clearance for OMNIPRO I'MRT, manufactured by Wellhofer Dosimetrie. The device is a Class 2 Radiology device with product code IYE cleared through the Traditional 510(k) pathway after a 94-day FDA review.

K031634 · Wellhofer Dosimetrie · Radiology device
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Aug 2003
Decision
94d
Days
Class 2
Risk

K031634 is an FDA 510(k) clearance for the OMNIPRO I'MRT. Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Wellhofer Dosimetrie (Uppsala, SE). The FDA issued a Cleared decision on August 29, 2003 after a review of 94 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Wellhofer Dosimetrie devices

FDA 510(k) Submission Details - K031634

510(k) Number K031634 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2003
Decision Date August 29, 2003
Days to Decision 94 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
13d faster than avg
Panel avg: 107d · This submission: 94d
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 487
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