ImageWorks

ImageWorks

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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,X-Ray,Extraoral Source,Digital (MUH) (9) Unit, X-Ray, Extraoral With Timer (EHD) (1)

Premarket Exempt

No

Clear

EVA SELECT - D83399924121000 Catalog Number : 9992412100

Device Description : EVA SELECT SIZE 1 SYSTEM

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT - D83399924121050 Catalog Number : 9992412105

Device Description : EVA SELECT SIZE 1 SENSOR

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT - D83399924122000 Catalog Number : 9992412200

Device Description : EVA SELECT SIZE 2 SYSTEM

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT - D83399924122050 Catalog Number : 9992412205

Device Description : EVA SELECT SIZE 2 SENSOR

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT DIRECT - D83399924131000 Catalog Number : 9992413100

Device Description : EVA SELECT DIRECT SIZE 1 SYSTEM

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT DIRECT - D83399924131050 Catalog Number : 9992413105

Device Description : EVA SELECT DIRECT SIZE 1 SENSOR ONLY

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT DIRECT - D83399924132000 Catalog Number : 9992413200

Device Description : EVA SELECT DIRECT SIZE 2 SYSTEM

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVA SELECT DIRECT - D83399924132050 Catalog Number : 9992413205

Device Description : EVA SELECT DIRECT SIZE 2 SENSOR ONLY

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

EVASOFT - D83399924908000 Catalog Number : 9992490800

Device Description : EVASOFT IMAGING SOFTWARE

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : MUH

Prescription Use : No

Device Count : 1

INTRASKAN DC - D83399927200000 Catalog Number : 9992720000

Device Description : INTRASKAN DC WITH 15" EXTENSION ARM

Device Class : 2

Duns Number: 833648087

Premarket Exempt : No

Product Code : EHD

Prescription Use : No

Device Count : 1

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