Cleared Special

K122644 - ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21

K122644 is an FDA 510(k) clearance for ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW..., 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 260-day FDA review.

K122644 · Siemens Medical Solutions USA, Inc. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2013
Decision
260d
Days
Class 2
Risk

K122644 is an FDA 510(k) clearance for the ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR 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 May 16, 2013 after a review of 260 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K122644

510(k) Number K122644 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2012
Decision Date May 16, 2013
Days to Decision 260 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
153d slower than avg
Panel avg: 107d · This submission: 260d
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 324
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K122644 · ARTIS ZEE/ZEEGO WITH CSX-10 DETECTOR SW VC21
Download PDF FDA Summary Siemens Medical Solut…