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) (10)

Premarket Exempt

No Yes

Clear

HDR X-ray Source 2.2 - 00858012005304 Catalog Number : S7551

Device Description : Axxent HDR X-Ray Source 50 cm HUT

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Balloon Applicator Kit - 00858012005311 Catalog Number : AB2060

Device Description : Balloon Applicator, 3-4 cm Spherical

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Balloon Applicator Kit - 00858012005328 Catalog Number : AB2061

Device Description : Balloon Applicator, 4-5 cm Spherical

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Balloon Applicator Kit - 00858012005335 Catalog Number : AB2062

Device Description : Balloon Applicator, 5-6 cm Spherical

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Balloon Applicator Kit - 00858012005342 Catalog Number : AB2063E

Device Description : Balloon Applicator, 5x7 cm Ellipsodial

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Surface Applicator Set Bundle 1 - 00858012005359 Catalog Number : SK1001

Device Description : Surface Applicator Bundle

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Axxent Radiation Shield - Rigid - 00858012005366 Catalog Number : F5350

Device Description : Rigid Shield Set

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Rigid Shield 4 cm - 00858012005373 Catalog Number : F5350-4

Device Description : Rigid Shield 4 cm

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Rigid Shield 5 cm - 00858012005380 Catalog Number : F5350-5

Device Description : Rigid Shield 5 cm

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

Rigid Shield 6 cm - 00858012005397 Catalog Number : F5350-6

Device Description : Rigid Shield 6 cm

Device Class : 2

Duns Number: 108870254

Premarket Exempt : No

Product Code : JAD

Prescription Use : No

Device Count : 1

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