Duns Number:557796065
Device Description: The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, an The Prudent is an Wireless/Wired flat panel x-ray detector system that interfaces with, and acquires and digitized x-ray exposures from, standard radiographic system. The Prudent detector is designed to be used in any environment that would typically use a radiographic cassette for examination of human anatomy. The digital x-ray detector is configurable in several options depending materials such as TFT array(amorphous silicon or Indium Gallium Zinc Oxide), TFT substrate (glass or polyimide), TFT Pixel pitch and Scintillator (CsI or Gadox). The detector will display high quality images in approximately five seconds over a wide range of dose setting.
Catalog Number
-
Brand Name
Prudent1717
Version/Model Number
Prudent1717
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)
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FDA Premarket Submission
K211108
Product Code
MQB
Product Code Name
Solid State X-Ray Imager (Flat Panel/Digital Imager)
Public Device Record Key
c89f0c5f-7315-4b83-8594-4602652a826b
Public Version Date
January 05, 2022
Public Version Number
1
DI Record Publish Date
December 28, 2021
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 |