Medical Device Registration

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

45-4576-8888

ta@ddd-diagnostic.dk

http://www.ddd-diagnostic.dk

U.S. Agent

Registrar Corp

144 Research Drive

Hampton VA, USA 23666

+1-757-224-0177

info@registrarcorp.com

www.registrarcorp.com

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

Valid2021 U.S. FDA Medical Device Establishment Registration

Danish Diagnostic Development A/S

Establishment Information

U.S. Agent

Listings on file with FDA

Device Listing

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Company Function(s)

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Device Listing

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Device Listing

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Device Listing

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