DEVICE: OrthoScan Mobile DI Mini C-arm (B225100000050)

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Device Record History
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Device Identifier (DI) Information
OrthoScan Mobile DI Mini C-arm
1000-0005
In Commercial Distribution

Ziehm-Orthoscan, Inc.
B225100000050
HIBCC

1
196554021 *Terms of Use
Image-intensified fluoroscopic x-ray system, mobile
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Device Characteristics
Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

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?
37649 Portable general-purpose fluoroscopic x-ray system, digital
A portable (moveable from one location to another, and easily reassembled) general-purpose diagnostic fluoroscopic x-ray system that uses real-time digital techniques for image capture, display and manipulation and is specifically designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging. It includes spot-film capabilities in addition to the fluoroscopic features and is intended to optimize the capability of users to visually and quantitatively evaluate the anatomy and physiological function of various targeted body areas in real-time. It is frequently used in conjunction with an ingested or injected x-ray contrast medium.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OXO Image-Intensified Fluoroscopic X-Ray System, Mobile
JAA System, X-Ray, Fluoroscopic, Image-Intensified
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K113708 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 32 and 131 Degrees Fahrenheit
Handling Environment Temperature: between 0 and 55 Degrees Celsius
Handling Environment Humidity: between 10 and 100 Percent (%) Relative Humidity
Handling Environment Atmospheric Pressure: between 500 and 1060 millibar
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Clinically Relevant Size

[?]
Size Type Text
No Device Sizes
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Device Record Status
03e45cdc-2f8f-4894-bdba-de1646dae546
August 02, 2023
4
March 07, 2017
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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

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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

[?]
480-503-8010
steve.seeman@orthoscan.com
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