Ddd-Diagnostic A/S

Ddd-Diagnostic A/S

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Filters

Device Class

Class-1 (A medical device with low to moderate risk that requires general controls) Class-2 (A medical device with a moderate to high risk that requires special controls) Class-3 (A medical device with high risk that requires premarket approval) Class-U (Unclassified)

Product Code

System, Tomography, Computed, Emission (KPS) (8) Camera, Scintillation (Gamma) (IYX) (1)

Premarket Exempt

No

Clear

C.Cam - 05711665001008 Catalog Number : 9VIR1200

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

CorCam - 05711665002005 Catalog Number : 9COR2370

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

CardioMD - 05711665002012 Catalog Number : 9PMS3060

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

CardioMD - 05711665002029 Catalog Number : 9PMS3060

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

QuantumCam - 05711665003002 Catalog Number : 9SYS2070

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

BodyMD - 05711665003019 Catalog Number : 9PMS3131

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

BodyMD - 05711665003026 Catalog Number : 9PMS3131

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

QuantumCam - 05711665003033 Catalog Number : 9SYS2070

Device Description : Gamma Camera System

Device Class : 2

Duns Number: 305116642

Premarket Exempt : No

Product Code : KPS

Prescription Use : No

Device Count : 1

SoloMobile - 05711665004009 Catalog Number : 9SOL2210

Device Description : Gamma Camera System

Device Class : 1

Duns Number: 305116642

Premarket Exempt : No

Product Code : IYX

Prescription Use : No

Device Count : 1

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