FDA.reportPublic FDA data

Dermascan C Ver. 3 USB

Primary DI
05710188039000
Brand
Dermascan C Ver. 3 USB
Company
Cortex Technology ApS
Model
08
Catalog number
A0390008
Device description
Ultrasound imaging system main unit
Published
2016-10-26
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYOSystem, Imaging, Pulsed Echo, Ultrasonic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYOSystem, Imaging, Pulsed Echo, UltrasonicRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K983945000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K983945000CORTEX DERMASCAN C ULTRASONIC SYSTEMCortex Technology Aps1999-03-17IYO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05710188039000PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05710188039000057101880390005710188039000

GMDN Terms#

Term, Definition table
TermDefinition
Ultrasound imaging system operator consoleA 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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+4598574100cortex@cortex.dk

Regulatory Flags#

DUNS number
306186800
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05710188020015CryoPro maxi19E02001192016-10-26
05710188020022CryoPro mini19E02002192016-10-26
05710188035293DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03529092016-10-26
05710188035309DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03530092016-10-26
05710188035316DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03531092016-10-26
05710188035330DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03533092016-10-26

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