Arterys Inc.

Address:255 Shoreline Drive,Redwood City,CA,94065,US

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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) (7) Automated Radiological Image Processing Software (QIH) (1)

Premarket Exempt

Clear

Arterys Cardio DL - 08624310003104 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Arterys Viewer - 08624310003203 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Arterys MICA - B664AMM50 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Arterys MICA - B664AMM60 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ, QIH

Prescription Use : Yes

Device Count : 1

Arterys Oncology DL - B664AOM40 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Arterys Viewer - B664AVM30 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

Arterys Cardio DL - B664CVM20 Catalog Number :

Device Class : 2

Duns Number: 078466835

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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