DEVICE: XRPad2 (00810751030009)
Device Identifier (DI) Information
XRPad2
4343 HWC-M
In Commercial Distribution
95510607
VAREX IMAGING WEST, LLC
4343 HWC-M
In Commercial Distribution
95510607
VAREX IMAGING WEST, LLC
XRpad2 4343 is a lightweight wireless cassette detector with advanced features enabling digital radiography as never seen before. Featuring best-in-class 100 um pixel size, direct deposition CsI scintillator and excellent DQE, XRpad2 4343 enables high resolution imaging with reduced X-ray exposure. Design of the second-generation XRpad is lightweight, robust and ergonomic, permitting easy lifting from table top. Automatic Exposure Detection, on-board corrections, and wireless access point mode make system integration quick and simple. New features of the XRpad2 4343 include fast preview, internal image storage, and magnetic connector for docking. Continuous imaging at up to 8 fps facilitates advanced applications such as tomosynthesis, dual energy subtraction, and image stitching.
Device Characteristics
Labeling does not contain MRI Safety Information | |
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GMDN
[?]GMDN© Term Code, Names and Definitions (*Terms of Use): GMDN® is a registered trademark of The GMDN Agency. All rights reserved. Used under licence from The GMDN Agency Ltd.
GMDN Term Code | GMDN Term Name | GMDN Term Definition | GMDN Term Status [?] | Implantable? |
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61108 | Indirect flat panel x-ray detector |
An electrically-powered, cassette-like device intended to be used as part of an x-ray system to detect x-ray images following exposure, and create a digital signal; it is not dedicated to imaging of a specific anatomy. It includes two types of transducing technology (i.e., indirect): a scintillator [e.g. caesium iodide (CsI)] screen converts x-ray energy into light, followed by the conversion of light into a digital signal by photodiode array. The image data can be sent to an appropriate processing unit through a wired or wireless connection (e.g., Wi-Fi). It may be used in place of a fixed detector in x-ray imaging systems, e.g., as part of a digital imaging conversion system.
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FDA Product Code
[?]Product Code | Product Code Name |
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MQB | Solid State X-Ray Imager (Flat Panel/Digital Imager) |
FDA Premarket Submission
FDA Premarket Submission Number [?] | Supplement Number [?] |
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K181526 | 000 |
Sterilization
Storage and Handling
[?]Storage and Handling |
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Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity |
Storage Environment Temperature: between 10 and 35 Degrees Celsius |
Clinically Relevant Size
[?]Size Type Text |
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Depth: 15.5 Millimeter |
Length: 460 Millimeter |
Width: 460 Millimeter |
Weight: 3.8 Kilogram |
Device Record Status
cd744f2e-9268-462a-ae83-4864f89b47c1
June 11, 2019
1
June 03, 2019
June 11, 2019
1
June 03, 2019
Alternative and Additional Identifiers Additional Identifiers
Package DI
[?]Package DI Number | Quantity per Package | Contains DI Package | Package Discontinue Date | Package Status | Package Type |
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No Package DIs found |
Secondary DI
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No Secondary DIs found |
Unit of Use DI
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Unit of Use DI Number:
No Unit of Use DI Numbers Found
CLOSE
Direct Marking (DM)
[?]Production Identifier(s) in UDI
[?]Customer Contact
[?]
+1(408) 496-1216
mi.customerservice@vareximaging.com
mi.customerservice@vareximaging.com