ACCUTOME, INC.

Address:3222 Phoenixville Pike,Malvern,PA,19355,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, Imaging, Pulsed Echo, Ultrasonic (IYO) (8) Transducer, Ultrasonic, Diagnostic (ITX) (4) Tonometer, Manual (HKY) (2)

Premarket Exempt

No Yes

Clear

AccuTip Cover - 00897826002109 Catalog Number : AX11526

Device Description : Sleeved

Device Class :

Duns Number: 048792816

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 100

AccuTip Cover - 00897826002116 Catalog Number : AX11286

Device Description : Bulk, non-sleeved

Device Class :

Duns Number: 048792816

Premarket Exempt : No

Product Code : HKY

Prescription Use : Yes

Device Count : 600

4Sight: Software Package - 00897826002147 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

B-scan Pro: Software Package - 00897826002154 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : Yes

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

UBM Plus: Software Package - 00897826002161 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : No

Device Count : 1

B-scan Plus: Software Package - 00897826002178 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : No

Device Count : 1

A-scan Plus Connect: Software Package - 00897826002185 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : No

Device Count : 1

B-scan Plus Software Package: Veterinary Version - 00897826002192 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

B-scan Pro Software Package: Veterinary Version - 00897826002208 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

UBM Software Package: Veterinary Version - 00897826002215 Catalog Number :

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

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