CardioGraphe

Basic Information

• Brand Name: CardioGraphe
• Primary DI: 07290016484007
• Version / Model: Spotlight
• Company Name: ARINETA LTD
• Labeler DUNS: 514896484
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2019-01-01
• Public Version: 1
• Public Version Date: 2019-02-01
• Public Version Status: New
• Public Device Record Key: e1c0e3a7-157e-48ff-8efa-2b49137790e4

Device Description

The CardioGraphe is a CT Scanner designed to provide images of scanned organs especially of the heart and cardiovascular system.

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
JAK	System, X-Ray, Tomography, Computed	Radiology	892.1750	2

GMDN Terms

Code	Name	Definition	Implantable	Status
37618	Full-body CT system	An assembly of diagnostic x-ray computed tomography (CT) devices with a gantry large enough to allow imaging of any part of the body. It includes designs with single or multiple fixed annular arrays of x-ray tubes and opposing detectors or those with x-ray tube(s) and opposing detector assemblies that rotate rapidly around a central axis point within the gantry imaging area. It can produce two and/or three-dimensional (3-D) cross-sectional (tomographic) images, including spiral CT or other special imaging applications at multiple specified angles in relation to body position. It may use a variety of digital techniques for information capture, image reconstruction, and display.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290016484007	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]
• Phone: [phone]
• Email: [email protected]

Premarket Submissions

Submission Number	Supplement Number
K161066	000

Device Sizes

Type	Value	Unit	Text
Device Size Text, specify			Gantry; Source to detector distance 854 mm
Device Size Text, specify			Gantry; Source to isocenter distance 450 mm
Device Size Text, specify			Focused Field of View 250 mm
Device Size Text, specify			Table; Horizontal range 150 cm
Device Size Text, specify			Table; Vertical range 45/50 cm to 82.5/87.5 cm

Storage Conditions

• Type: Storage Environment Temperature
• Temperature Range: 4 – 27 Degrees Celsius
• Type: Storage Environment Humidity
• Temperature Range: 20 – 60 Percent (%) Relative Humidity
• Type: Handling Environment Temperature
• Temperature Range: -20 – 60 Degrees Celsius
• Type: Handling Environment Humidity
• Temperature Range: 5 – 95 Percent (%) Relative Humidity