Duns Number:689533016
Device Description: AJEX9015H is a portable X-ray unit designed for ease usage.Applying high frequency invert 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
Catalog Number
AJEX9015H
Brand Name
Portable X-ray Unit
Version/Model Number
AJEX9015H
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
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
K052341
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
ed7c6d55-06eb-45db-a0a6-9e7ff5f7d234
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 04, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |