Cleared Special

Optima XR646 HD (K173612) - FDA 510(k) Clearance

Class II Radiology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K173612 · Ge Hualun Medical Systems Co. , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2017
Decision
19d
Days
Class 2
Risk

K173612 is an FDA 510(k) clearance for the Optima XR646 HD. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Ge Hualun Medical Systems Co. , Ltd. (Beijing, CN). The FDA issued a Cleared decision on December 11, 2017 after a review of 19 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Ge Hualun Medical Systems Co. , Ltd. devices

Submission Details

510(k) Number K173612 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 2017
Decision Date December 11, 2017
Days to Decision 19 days
Submission Type Special
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
88d faster than avg
Panel avg: 107d · This submission: 19d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 118
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K173612.
Amrad Medical AAU Digital Radiography System
K173823 · Summit Industries, LLC · Feb 2018
uDR 780i
K173953 · Shanghai United Imaging Healthcare Co., Ltd. · Jan 2018
GU60A & GU60A-65
K173828 · Samsung Electronics Co., Ltd. · Jan 2018
Multix Fusion Max
K162971 · Siemens Medical Solutions USA, Inc. · Nov 2016
MULTIX FUSION VA30 & VA40
K142049 · Siemens Medical Solutions USA, Inc. · Dec 2014
YSIO MAX
K133259 · Siemens Medical Solutions USA, Inc. · Jan 2014