Cleared Traditional

K061534 - ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM

K061534 is an FDA 510(k) clearance for ZIEHM VISION FD DIGITAL MOBILE IMAGING ..., manufactured by Ziehm Imaging, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K061534 · Ziehm Imaging, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2006
Decision
35d
Days
Class 2
Risk

K061534 is an FDA 510(k) clearance for the ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Ziehm Imaging, Inc. (Riverside, US). The FDA issued a Cleared decision on July 7, 2006 after a review of 35 days - a notably fast clearance 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: 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 - K061534

510(k) Number K061534 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 02, 2006
Decision Date July 07, 2006
Days to Decision 35 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
72d faster than avg
Panel avg: 107d · This submission: 35d
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.

Regulatory Peers - OWB Interventional Fluoroscopic X-ray System

All 324
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K061163 · Ge Medical Systems, LLC · Jun 2006
K061534 · ZIEHM VISION FD DIGITAL MOBILE IMAGING SYSTEM
Download PDF FDA Summary Ziehm Imaging, Inc.