FDA.reportPublic FDA data

DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE

Primary DI
05710188035309
Brand
DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE
Company
Cortex Technology ApS
Model
09
Catalog number
G0353009
Device description
High frequency ultrasound probe
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
05710188035309PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05710188035309057101880353095710188035309

GMDN Terms#

Term, Definition table
TermDefinition
Extracorporeal ultrasound imaging transducer, hand-heldA hand-held noninvasive component of an ultrasound imaging assembly designed to be moved over the intact surface of a patient's body, typically with a coupling gel, during a variety of extracorporeal ultrasound imaging procedures (non-dedicated). Sometimes referred to as an ultrasound probe, it converts electric voltages into ultrasound which it transmits, detects resulting echoes, and transmits a proportional signal/data to an ultrasound system controller for image processing and display. This is a reusable device.

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
05710188035316DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03531092016-10-26
05710188035330DERMASCAN HIGH FREQUENCY ULTRASOUND PROBE09G03533092016-10-26
05710188039000Dermascan C Ver. 3 USB08A03900082016-10-26

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