Icad, Inc.

Address:4 Townsend West, Suite 9,Nashua,NH,03063,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

Radiological Computer Assisted Detection/Diagnosis Software For Lesions Suspicious For Cancer (QDQ) (2) System, Digital Image Communications, Radiological (LMD) (2) System, Therapeutic, X-Ray (JAD) (2) System, Image Processing, Radiological (LLZ) (1)

Premarket Exempt

No Yes

Clear

PowerLook Density Assessment V3.4 - 00858012005922 Catalog Number : D70141, D70142, D70160

Device Description : "PowerLook Density Assessment 3.4 is a software application intended for use wit "PowerLook Density Assessment 3.4 is a software application intended for use with DBT 2D images from tomosynthesis exams. PowerLook Density Assessment 3.4 provides a BI-RADS 5th Edition breast density category to aid health care professionals in the assessment of breast tissue composition. PowerLook Density Assessment 3.4 produces adjunctive information. It is not a diagnostic aid.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : LLZ

Prescription Use : Yes

Device Count : 1

PowerLook Tomo Detection (ProFound AI) - 00858012005939 Catalog Number :

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : QDQ

Prescription Use : Yes

Device Count : 1

PowerLook - 00858012005946 Catalog Number :

Device Class : 1

Duns Number: 108870254

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

ProFound AI - 00858012005960 Catalog Number :

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : QDQ

Prescription Use : Yes

Device Count : 1

PowerLook - 00858012005977 Catalog Number :

Device Class : 1

Duns Number: 108870254

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : Yes

Device Count : 1

Balloon Applicator - 00858012005984 Catalog Number : AB2070

Device Description : 3-4 cm Spherical, Extended Length

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : Yes

Device Count : 1

Balloon Applicator - 00858012005991 Catalog Number : AB2071

Device Description : 4-5 cm Spherical Extended Length

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : Yes

Device Count : 1

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