FDA Registration Number: 9616576

Last Validated: September 15, 2021

Status: Valid

Valid2021 U.S. FDA Medical Device Establishment Registration

Danish Diagnostic Development A/S

Establishment Information

Kaervej 12
HORSHOLM Hovedstaden, DK 2970

U.S. Agent

Registrar Corp
144 Research Drive
Hampton VA, USA 23666
Registration of a device establishment, assignment of a registration number, or listing of a medical device does not in any way denote approval of the establishment or its products by U.S. FDA.

Listings on file with FDA

Device Name Product Code Status Last Validated  
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

CARDIO MD-AC
Camera, Scintillation (Gamma) IYX Valid September 14, 2021

Device Listing

Device Name

Camera, Scintillation (Gamma)

Product Code

IYX

Company Function(s)

Manufacturer

Proprietary Name(s)

System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

CARDIO MD
CorCam
CardioMD
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

C.CAM-AC
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

BodyMD
QuantumCam
Body MD
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

C.CAM
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

UNICORN Model SYS0630
System, Tomography, Computed, Emission KPS Valid September 14, 2021

Device Listing

Device Name

System, Tomography, Computed, Emission

Product Code

KPS

Company Function(s)

Manufacturer

Proprietary Name(s)

QuantumCam
Body MD

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