Duns Number:687797852
Device Description: A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar A component of an x-ray system used in diagnostic x-ray imaging applications, e.g., planar x-ray imaging. It typically consists of a housing containing lead foil strips separated by x-ray transparent spacers. These spacers or "interspaces" are filled with aluminium (Al) or another x-ray transparent (radiolucent) organic compound. Radiographic grids are placed between the x-ray target (patient) and the x-ray film and are used to absorb scatter radiation, and improve radiographic image contrast. It typically comes in two patterns, linear and crossed. Most are focused to a line in space called a convergent line, but can be used over a variable range called the focal distance.
Catalog Number
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Brand Name
Box for radiographic Grid-1000(G5(outside 620mmx140mmx590mm),packing quantity:9)
Version/Model Number
Grid-1000
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)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
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Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K945327
Product Code
IXJ
Product Code Name
Grid, Radiographic
Public Device Record Key
597cf481-5452-4db8-8456-a46ae7b92132
Public Version Date
November 19, 2020
Public Version Number
1
DI Record Publish Date
November 11, 2020
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 | 36 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 11 |