Duns Number:688209954
Device Description: 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5kW3. Fluoroscopy Mode - F-mode: 0.5~1 1. Line Voltage: 220~230V, 50/60Hz2. Output Power: 5kW3. Fluoroscopy Mode - F-mode: 0.5~10mA - P-mode: 0.5~20mA - Boost mode: 30mA - DS mode: 10~30mA4. Radiography Mode - kV range: 40~125kV, mA range: 20~100mA, mAs range: 0.8~200mAs5. X-ray Tube - XRR-2551(Rotating Type), Focal Spot: 0.3/0.6, Target Angle: 10degree, Anode Heat Storage: 210kHU6. Image Intensifier - E5830SD-PA4(TOSHIBA), 9inch7. Camera - CCD, Resolution: 1K X 1K
Catalog Number
ECO-ER-CAT-002C
Brand Name
NA
Version/Model Number
Anyview-500R
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
K160279
Product Code
JAA
Product Code Name
System, X-Ray, Fluoroscopic, Image-Intensified
Public Device Record Key
6278038c-5aea-40b7-a238-b9c63c550101
Public Version Date
July 06, 2018
Public Version Number
3
DI Record Publish Date
November 05, 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 |