Portable X-ray Unit - AJEX1200H is a portable X-ray unit designed for - AJEX Meditech Ltd

Duns Number:689533016

Device Description: AJEX1200H is a portable X-ray unit designed for ease usage. Applying high frequency invert 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

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More Product Details

Catalog Number

AJEX1200H

Brand Name

Portable X-ray Unit

Version/Model Number

AJEX1200H

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

-

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K122298

Product Code Details

Product Code

IZL

Product Code Name

System, X-Ray, Mobile

Device Record Status

Public Device Record Key

919f3bd2-53ec-4f4e-a5fb-641c9d61c09c

Public Version Date

July 06, 2018

Public Version Number

3

DI Record Publish Date

November 04, 2016

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"AJEX MEDITECH LTD" Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5