WHALE

Basic Information

• Brand Name: WHALE
• Primary DI: 06970528550018
• Version / Model: DigiArc 100AU
• Company Name: Beijing East Whale Imaging Technology Co.,Ltd.
• Labeler DUNS: 529847741
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-09-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 2e97bae1-c486-4bcd-9120-a680a1eac98c

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	Radiology	892.1650	2
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37646	Mobile general-purpose fluoroscopic x-ray system, digital	A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium. Images can be both real-time and delayed formats.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	06970528550018	GS1

Premarket Submissions

Submission Number	Supplement Number
K151280	000

Device Sizes

Type	Value	Unit	Text
Weight	600	Kilogram
Width	922	Millimeter
Length	2234	Millimeter
Height	2540	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -10 – 55 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 10 – 85 Percent (%) Relative Humidity
• Type: Storage Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal