Dermascan C Ver. 3 USB

Basic Information

• Brand Name: Dermascan C Ver. 3 USB
• Primary DI: 05710188039000
• Version / Model: 08
• Catalog Number: A0390008
• Company Name: Cortex Technology ApS
• Labeler DUNS: 306186800
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-10-26
• Public Version: 3
• Public Version Date: 2018-07-06
• Public Version Status: Update
• Public Device Record Key: b8e804ab-755d-422a-8d36-b165a93dc8b4

Device Description

Ultrasound imaging system main unit

Device Characteristics

• Single Use: No
• Prescription Use (Rx): No
• 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: No
• 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
IYO	System, Imaging, Pulsed Echo, Ultrasonic	Radiology	892.1560	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40971	Ultrasound imaging system operator console	A device that is a component of a diagnostic ultrasound imaging system that functions as the primary control panel. It includes hardware and software that allows for image display, processing, analysis, archiving and retrieval. It typically includes the capabilities to be interfaced into a picture archiving and communication system (PACS), a local area network (LAN), a radiology information system (RIS) or a hospital information system (HIS). It contains the primary controls for the direct operation of the ultrasound system and is typically incorporated in the system design as is the case with mobile or portable ultrasound systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	05710188039000	GS1

Customer Contacts

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

Premarket Submissions

Submission Number	Supplement Number
K983945	000