WHALE

Basic Information

• Brand Name: WHALE
• Primary DI: 06970528550063
• Version / Model: B6
• 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: 2017-05-04
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: 1dcbfd2e-1ff2-4376-80eb-7dc040c50ee0

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
JAA	System, X-Ray, Fluoroscopic, Image-Intensified	Radiology	892.1650	2
OXO	Image-Intensified Fluoroscopic X-Ray System, Mobile	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	06970528550063	GS1

Premarket Submissions

Submission Number	Supplement Number
K163429	000

Device Sizes

Type	Value	Unit	Text
Weight	150	Kilogram
Height	1760	Millimeter
Width	670	Millimeter
Length	1010	Millimeter
Weight	529	Kilogram
Height	2476	Millimeter
Width	920	Millimeter
Length	2820	Millimeter

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: -20 – 55 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 10 – 90 Percent (%) Relative Humidity
• Type: Handling Environment Atmospheric Pressure
• Temperature Range: 70 – 106 KiloPascal