VOLPARA HEALTH TECHNOLOGIES LIMITED

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

System, Image Processing, Radiological (LLZ) (6) Instrument, Quality-Assurance, Radiologic (LHO) (3) System, Digital Image Communications, Radiological (LMD) (1)

Premarket Exempt

No Yes

Clear

VolparaDensity - 09421904268029 Catalog Number :

Device Description : VolparaDensity 3.2 (Volpara Imaging Software 1.5.2)

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDoseRT - 09421904268036 Catalog Number :

Device Description : VolparaDoseRT 3.2

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

VolparaDoseSR - 09421904268043 Catalog Number :

Device Description : VolparaDoseSR 3.2

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

Volpara Density Map - 09421904268050 Catalog Number :

Device Description : Volpara Density Map 3.2

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaServer - 09421904268074 Catalog Number :

Device Description : VolparaServer 1.3

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

VolparaDensity - 09421904268098 Catalog Number :

Device Description : VolparaDensity 3.3 (Volpara Imaging Software 1.5.3 and 1.5.4)

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDoseRT - 09421904268104 Catalog Number :

Device Description : VolparaDoseRT 3.3 (including VolparaPressure and VolparaPosition)

Device Class : 1

Duns Number: 590762212

Premarket Exempt : Yes

Product Code : LHO

Prescription Use : No

Device Count : 1

Volpara Density Map - 09421904268128 Catalog Number :

Device Description : Volpara Density Map 3.3

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDensity - 09421904268166 Catalog Number :

Device Description : VolparaDensity 3.4.1 (Volpara Imaging Software 1.5.5.1)

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

VolparaDensity - 09421904268241 Catalog Number :

Device Class : 2

Duns Number: 590762212

Premarket Exempt : No

Product Code : LLZ

Prescription Use : No

Device Count : 1

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