Cleared Special

K141574 - ARTIS ZEE/ZEEGO SW VC21

K141574 is an FDA 510(k) clearance for ARTIS ZEE/ZEEGO SW VC21, manufactured by Siemens Medical Solutions USA, Inc.. The device is a Class 2 Radiology device with product code OWB cleared through the Special 510(k) pathway after a 85-day FDA review.

K141574 · Siemens Medical Solutions USA, Inc. · Radiology device
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Sep 2014
Decision
85d
Days
Class 2
Risk

K141574 is an FDA 510(k) clearance for the ARTIS ZEE/ZEEGO SW VC21. Classified as Interventional Fluoroscopic X-ray System (product code OWB), Class II - Special Controls.

Submitted by Siemens Medical Solutions USA, Inc. (Mavern, US). The FDA issued a Cleared decision on September 5, 2014 after a review of 85 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Siemens Medical Solutions USA, Inc. devices

FDA 510(k) Submission Details - K141574

510(k) Number K141574 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 12, 2014
Decision Date September 05, 2014
Days to Decision 85 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 107d · This submission: 85d
Pathway characteristics
Modification to existing cleared device.

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 293
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