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

Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (POK) (3) Radiological Computer-Assisted Triage And Notification Software (QAS) (3) System, Image Processing, Radiological (LLZ) (3)

Premarket Exempt

Clear

Rapid - B7671R520 Catalog Number : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, POK, QAS

Prescription Use : Yes

Device Count : 1

Rapid - B7671R521 Catalog Number : Rapid

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : POK, LLZ, QAS

Prescription Use : Yes

Device Count : 1

Rapid - B7671R522 Catalog Number : Rapid

Device Description : Rapid System Update

Device Class : 2

Duns Number: 079477740

Premarket Exempt : No

Product Code : LLZ, POK, QAS

Prescription Use : Yes

Device Count : 1

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