Cleared Traditional

K160984 - MultiScan G-Arm System

K160984 is an FDA 510(k) clearance for MultiScan G-Arm System, manufactured by Beijing East Whale Imaging Technology Co., Ltd.. The device is a Class 2 Radiology device with product code OXO cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K160984 · Beijing East Whale Imaging Technology Co., Ltd. · Radiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2016
Decision
104d
Days
Class 2
Risk

K160984 is an FDA 510(k) clearance for the MultiScan G-Arm System. Classified as Image-intensified Fluoroscopic X-ray System, Mobile (product code OXO), Class II - Special Controls.

Submitted by Beijing East Whale Imaging Technology Co., Ltd. (Beijing, CN). The FDA issued a Cleared decision on July 20, 2016 after a review of 104 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K160984

510(k) Number K160984 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 2016
Decision Date July 20, 2016
Days to Decision 104 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 107d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

OXO Device Classification - Class 2, Special Controls

Product Code OXO Image-intensified Fluoroscopic X-ray System, Mobile
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1650
Definition Fluoroscopy Of The Human Body.
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 - OXO Image-intensified Fluoroscopic X-ray System, Mobile

All 74
Devices cleared under the same product code (OXO) and FDA review panel - the closest regulatory comparables to K160984.
OEC Elite
K172550 · Ge Oec Medical Systems, Inc. · Nov 2017
OEC Elite MiniView
K171800 · Ge Hualun Medical Systems Co. , Ltd. · Jul 2017
B6
K163429 · Beijing East Whale Imaging Technology Co., Ltd. · Jan 2017
OEC Elite MiniView
K160131 · Ge Hangwei Medical Systems Co., Ltd. · Jun 2016
GEMSS Medical System Surgical Mobile Fluoroscopic X-ray System
K160065 · Gemss Medical Systems Co., Ltd. · May 2016
MultiScan G-Arm System
K151280 · Beijing East Whale Imaging Technology Co., Ltd. · Sep 2015