Duns Number:557796065
Device Description: ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat pa ATAL 9 is a high-resolution digital X-Ray imaging device commonly referred to as a flat paneldetect. A built-in a-Si TFT flat panel type digital sensor receives X-Ray and converts to digital image.X-Ray photons are converted to digital output signals. The digital signals are then read out by TFTs.The image data file is saved at the computer for display, which can be linked with PACS and printedby DICOM printer through acquisition software. It is specifically designed to deliver X-Ray imagingfor medical, veterinary and industrial applications.
Catalog Number
-
Brand Name
ATAL 9
Version/Model Number
ATAL 9 (Wired Detector)
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"
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For Single-Use
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Prescription Use (Rx)
-
Over the Counter (OTC)
-
Kit
-
Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K152151
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
5f5fa70f-8337-4904-b61b-0cf5c1fabe5d
Public Version Date
May 07, 2019
Public Version Number
6
DI Record Publish Date
January 18, 2017
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. | 15 |