AJEX Meditech Ltd

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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, Mobile (IZL) (5)

Premarket Exempt

Clear

Portable X-ray Unit - 08809250370060 Catalog Number : AJEX135H

Device Description : AJEX135H is a portable X-ray unit designed for ease usage. Applying high frequen AJEX135H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator.- X-ray tube voltage(kV) : 50 ~ 100 kV- X-ray tube curren time product(mAs) : 0.4 ~ 105 mAs

Device Class : 2

Duns Number: 689533016

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

Portable X-ray Unit - 08809250370091 Catalog Number : AJEX9015H

Device Description : AJEX9015H is a portable X-ray unit designed for ease usage.Applying high freque AJEX9015H is a portable X-ray unit designed for ease usage.Applying high frequency inverter type X-ray generator.- X-ray tube voltage(kV) : 50 ~ 90 kV- X-ray tube current time product(mAs) : 0.3 ~ 30 mAs

Device Class : 2

Duns Number: 689533016

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

Portable X-ray Unit - 08809250370138 Catalog Number : AJEX240H

Device Description : AJEX240H is a Portable X-ray unit designed for ease usage.Applying high frequenc AJEX240H is a Portable X-ray unit designed for ease usage.Applying high frequency inverter type X-ray generator.- X-ray tube voltage(kV):40-120kV- X-ray tube time product(mAs): 0.4-120mAs

Device Class : 2

Duns Number: 689533016

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

Portable X-ray Unit - 08809250370169 Catalog Number : AJEX1200H

Device Description : AJEX1200H is a portable X-ray unit designed for ease usage. Applying high freque AJEX1200H is a portable X-ray unit designed for ease usage. Applying high frequency inverter type X-ray generator.- X-ray tube voltage(kV) : 40 ∼ 120 kV- X-ray tube current time product(mAs) : 0.6 ∼ 168 mAs

Device Class : 2

Duns Number: 689533016

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

Portable X-ray Unit - 08809259370138 Catalog Number : AJEX240H

Device Description : AJEX240H is a portable X-ray unit designed for ease usage.Applying high frequen AJEX240H is a portable X-ray unit designed for ease usage.Applying high frequency inverter type X-ray generator.- X-ray tube voltage(kV) : 40 ~ 120 kV- X-ray tube current time product(mAs) : 0.4 ~ 120 mAs

Device Class : 2

Duns Number: 689533016

Premarket Exempt : No

Product Code : IZL

Prescription Use : Yes

Device Count : 1

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