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) (5) Transducer, Ultrasonic, Diagnostic (ITX) (3)

Premarket Exempt

No Yes

Clear

B-scan Plus- VET - 00897826002222 Catalog Number : 24-6100-V

Device Description : Veterinary

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO, ITX

Prescription Use : Yes

Device Count : 1

B-scan Pro- VET - 00897826002239 Catalog Number : 24-6400-V

Device Description : Veterinary

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

Pachpen- VET - 00897826002253 Catalog Number : 24-5100-V

Device Description : Veterinary

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

A-scan Plus Connect- VET - 00897826002260 Catalog Number : 24-4400-V

Device Description : Veterinary

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : ITX, IYO

Prescription Use : Yes

Device Count : 1

UBM- VET - 00897826002277 Catalog Number :

Device Description : Veterinary

Device Class : 2

Duns Number: 048792816

Premarket Exempt : No

Product Code : IYO

Prescription Use : Yes

Device Count : 1

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