VOLPARA HEALTH TECHNOLOGIES LIMITED

Address:Level 14-15, Simpl House,Wellington Central,NZ

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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

Instrument, Quality-Assurance, Radiologic (LHO) (4) System, Image Processing, Radiological (LLZ) (3)

Premarket Exempt

No Yes

Clear

VolparaDensity - 09421904268258 Catalog Number :

Device Description : VolparaDensity 3.4.2

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDoseRT - 09421904268265 Catalog Number :

Device Description : VolparaDoseRT 3.4.2

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

VolparaDoseSR - 09421904268272 Catalog Number :

Device Description : VolparaDoseSR 3.4.2

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

Volpara Density Map - 09421904268289 Catalog Number :

Device Description : Volpara Density Map 3.4.2

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDoseRT - 09421904268296 Catalog Number :

Device Description : VolparaDoseRT 4.0

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

VolparaDoseSR - 09421904268302 Catalog Number :

Device Description : VolparaDoseSR 4.0

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

Volpara Density Map - 09421904268319 Catalog Number :

Device Description : Volpara Density Map 4.0

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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