Icad, Inc.

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

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Premarket Exempt
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Device Class : 1

Duns Number: 108870254

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

Device Class : 1

Duns Number: 108870254

Premarket Exempt : Yes

Product Code : LMD

Prescription Use : No

Device Count : 1

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-01-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-12-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-03-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-04-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-05-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : DSC010-07-US

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1

- Catalog Number : D4D0147

Device Description : The SecondLook Computer-Aided Detection (CAD) system for mammography is intended The SecondLook Computer-Aided Detection (CAD) system for mammography is intended to identify and mark regions of interest on screening and diagnostic mammograms from full-field digital mammography (FFDM) systems to bring them to the attention of the radiologist after an initial reading has been completed. Thus the system prompts the radiologist to areas on mammograms for second review only.Field Replacement System

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : MYN

Prescription Use : Yes

Device Count : 1