QLARITY IMAGING, LLC

Address:330 N Wabash,Chicago,IL,60611,US

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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) (2) Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer (POK) (1)

Premarket Exempt

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QuantX - B80711 Catalog Number : 1

Device Description : QuantX is a software program that analyzes patient breast images, and is designe QuantX is a software program that analyzes patient breast images, and is designed to aid radiologists in the characterization of lesions as part of high-risk screening or diagnostic work-up.

Device Class : 2

Duns Number: 108968505

Premarket Exempt : No

Product Code : POK

Prescription Use : Yes

Device Count : 1

QuantX - B80721 Catalog Number : 2

Device Description : The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assi The QuantX Breast MRI Biopsy Guidance Plugin is a software application that assists users of the QuantX software device in planning MRI guided interventional procedures.

Device Class : 2

Duns Number: 108968505

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

QuantX - B80731 Catalog Number : 3

Device Description : QuantX is a software program that is used to view and analyze patient breast images.

Device Class : 2

Duns Number: 108968505

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

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