Ischemaview, Inc.

Ischemaview, Inc.

Address:1120 Washington Ave,Golden,CO,80401,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) (10) Radiological Computer-Assisted Triage And Notification Software (QAS) (8) Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (POK) (3)

Premarket Exempt

No

Clear

RAPID - B761RAPID48302 Catalog Number : RAPID

Device Description : RAPID is a Platform for brain image analysis.

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

RAPID - B761RAPID49101 Catalog Number : Rapid

Device Description : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

RAPID - B761RAPID500 Catalog Number : Rapid

Device Description : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS

Prescription Use : Yes

Device Count : 1

RAPID - B761RAPID5010 Catalog Number :

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS

Prescription Use : Yes

Device Count : 1

RAPID - B761RAPID5020 Catalog Number :

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS

Prescription Use : Yes

Device Count : 1

RAPID - B761RAPID50210 Catalog Number : Rapid

Device Description : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS

Prescription Use : Yes

Device Count : 1

Rapid - B761RAPID510 Catalog Number : Rapid 5.1

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS, POK

Prescription Use : Yes

Device Count : 1

Rapid - B7671R5030 Catalog Number :

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, QAS

Prescription Use : Yes

Device Count : 1

Rapid - B7671R511 Catalog Number : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : POK, QAS, LLZ

Prescription Use : No

Device Count : 1

Rapid - B7671R512 Catalog Number : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : POK, QAS, LLZ

Prescription Use : Yes

Device Count : 1

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