DEVICE: X-CEL X-RAY CORPORATION (B216HDR715A401)

Device Identifier (DI) Information

X-CEL X-RAY CORPORATION
HDR-715A-40
In Commercial Distribution

ARQUILLA, INC.
B216HDR715A401
HIBCC

1
062469945 *Terms of Use
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

[?]

GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Stationary basic diagnostic x-ray system, analogue An assembly of devices that comprise a general-purpose stationary diagnostic x-ray system used in a variety of routine planar x-ray imaging applications. It is typically an x-ray film based system that use analogue or analogue-to-digital techniques for image capture and display. The stationary design requires it to be installed and used in a fixed location within a building or in a transportation van (mobile imaging facility). This system consists of modular configurations that can be upgraded by the addition of hardware/software components or accessories. This GMDN code does not cover systems with fluoroscopic or tomographic capabilities.
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FDA Product Code

[?]
Product Code Product Code Name
KPR System, X-Ray, Stationary
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K811230 000
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Sterilization

No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
Handling Environment Temperature: between 50 and 90 Degrees Fahrenheit
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status

75fd4411-c219-40da-9806-bc4cf386af4d
July 06, 2018
3
August 15, 2016
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Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]
Package DI Number Quantity per Package Contains DI Package Package Discontinue Date Package Status Package Type
No Package DIs found
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Secondary DI

[?]
Issuing Agency [?] Secondary DI Number
No Secondary DIs found
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Unit of Use DI

[?]
Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]
No
No
None
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Production Identifier(s) in UDI

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
8154552470
guido@xcelxray.com
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