Cleared Traditional

K142740 - Ziehm Vision RFD 3D

K142740 is an FDA 510(k) clearance for Ziehm Vision RFD 3D, manufactured by Ziehm Imaging GmbH. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 194-day FDA review.

K142740 · Ziehm Imaging GmbH · Radiology device
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Apr 2015
Decision
194d
Days
Class 2
Risk

K142740 is an FDA 510(k) clearance for the Ziehm Vision RFD 3D. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ziehm Imaging GmbH (Nuremberg, DE). The FDA issued a Cleared decision on April 6, 2015 after a review of 194 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1650 - 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 Ziehm Imaging GmbH devices

FDA 510(k) Submission Details - K142740

510(k) Number K142740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 2014
Decision Date April 06, 2015
Days to Decision 194 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
87d slower than avg
Panel avg: 107d · This submission: 194d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OWB Device Classification - Class 2, Special Controls

Product Code OWB Interventional Fluoroscopic X-ray System
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Interventional Fluoroscopy
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.

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All 246
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