Icad, Inc.

Address:4 Townsend West, Suite 9,Nashua,NH,03063,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, Therapeutic, X-Ray (JAD) (5) System, Applicator, Radionuclide, Remote-Controlled (JAQ) (3) Analyzer,Medical Image (MYN) (1) Shield, Protective, Personnel (KPY) (1)

Premarket Exempt

No Yes

Clear

Vaginal Applicator, 35mm - 00858012005502 Catalog Number : AG3035

Device Description : Vaginal Applicator 35 mm

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Axxent Standard Controller - 00858012005519 Catalog Number : XP1100

Device Description : Axxent Standard Controller

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Axxent Surface Controller - 00858012005526 Catalog Number : XP1200

Device Description : Axxent Surface Controller

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Cervical Applicator Set, Bundle 1 - 00858012005533 Catalog Number : CG1001

Device Description : Cervical Applicator Bundle 1

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Cervical Applicator Set, Bundle 2 - 00858012005540 Catalog Number : CG1002

Device Description : Cervical Applicator Bundle 2

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Cervical Applicator Set - 00858012005557 Catalog Number : CG1000

Device Description : Cervical Applicator Set

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAQ

Prescription Use : No

Device Count : 1

Flexishield Radiation Absorber - 00858012005588 Catalog Number : F5201

Device Description : Flexishield Radiation Absorber, Box

Device Class : 1

Duns Number: 108870254

Premarket Exempt : Yes

Product Code : KPY

Prescription Use : No

Device Count : 1

Surface Applicator Set - 00858012005595 Catalog Number : SK1000

Device Description : Surface Applicator Set

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

PowerLook AMP PRO with SecondLook Digital - 00858012005601 Catalog Number : DSC017-01-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

Surface Applicator Cone, 10 mm - 00858012005618 Catalog Number : SK1010

Device Description : Surface Applicator Cone, 10mm

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

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