Duns Number:688209954
Device Description: Input Power: 200V~240V, 50/60HzOutput Power: 3.2kWKVP range: 40~100kVmA range: 25~60mAmAs Input Power: 200V~240V, 50/60HzOutput Power: 3.2kWKVP range: 40~100kVmA range: 25~60mAmAs range: 0.4~100mAsX-ray Tube: D-205BFocal Sport: 2.0 x 2.0mmTarget Angle: 20 degreesAnode heat storage: 40kHU
Catalog Number
ECO-ER-CAT-001P
Brand Name
NA
Version/Model Number
EPX-F3200
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)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
IZL
Product Code Name
System, X-Ray, Mobile
Public Device Record Key
63c682bc-043a-423a-9b9c-482e59932a5a
Public Version Date
November 16, 2020
Public Version Number
4
DI Record Publish Date
September 28, 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 |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 5 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |