Cleared Special

K151280 - MultiScan G-Arm System

K151280 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 Special 510(k) pathway after a 139-day FDA review.

K151280 · 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
Sep 2015
Decision
139d
Days
Class 2
Risk

K151280 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 September 30, 2015 after a review of 139 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. 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 - K151280

510(k) Number K151280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 2015
Decision Date September 30, 2015
Days to Decision 139 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
32d slower than avg
Panel avg: 107d · This submission: 139d
Pathway characteristics
Modification to existing cleared device.

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 K151280.
MultiScan G-Arm System
K160984 · Beijing East Whale Imaging Technology Co., Ltd. · Jul 2016
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
DIGIARC 100AU+
K141672 · Beijing East Whale Imaging Technology Co., Ltd. · Jul 2014
ORTHOSCAN FD MINI C-ARM
K133174 · Orthoscan, Inc. · Mar 2014
G-ARM MULTISCAN SYSTEM
K131423 · Beijing East Whale Imaging Technology Co., Ltd. · Nov 2013