Duns Number:688209954
Device Description: LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 32kW(400mA@80kV, 320mA@100kV, 250mA@125kV) LINE POWER RATING: 230V, 50/60HzOUTPUT RATING: 32kW(400mA@80kV, 320mA@100kV, 250mA@125kV) KVP range: 40~125kVpmA range: 10~400mAmAs Range: 0.1~400mAs
Catalog Number
ECO-ER-CAT-001S
Brand Name
N/A
Version/Model Number
SXG-32R
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
IZO
Product Code Name
Generator, High-Voltage, X-Ray, Diagnostic
Public Device Record Key
0adccd6a-e089-4832-a2be-e12dc33d0395
Public Version Date
March 29, 2018
Public Version Number
2
DI Record Publish Date
October 27, 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 |