DEVICE: OEC (00840682145541)

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Device Record History
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Device Identifier (DI) Information
OEC
One CFD
In Commercial Distribution

GE Hualun Medical Systems Co., Ltd
00840682145541
GS1

1
554408665 *Terms of Use
MEDICAL DEVICE, UDI LABEL PLACEMENT, OEC One CFD
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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?
37646 Mobile general-purpose fluoroscopic x-ray system, digital
A mobile (within an imaging facility) general-purpose diagnostic fluoroscopic x-ray system that uses a C-arm and digital techniques for image capture, display and manipulation and is designed to be used in a variety of general-purpose applications requiring real-time fluoroscopic imaging capabilities. 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. Images can be both real-time and delayed formats.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
OWB Interventional fluoroscopic x-ray system
JAA System, x-ray, fluoroscopic, image-intensified
OXO Image-intensified fluoroscopic x-ray system, mobile
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K182626 000
K240828 000
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Sterilization
No
No
Sterilization Method [?]
No Sterilization Methods Found
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Storage and Handling

[?]
Storage and Handling
No storage/handling found
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Clinically Relevant Size

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Size Type Text
No Device Sizes
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Device Record Status
ea6dfeb3-6cb1-4b36-9c81-e98266ec82e5
June 09, 2025
3
August 09, 2019
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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

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Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

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No
No
None
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Production Identifier(s) in UDI

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No
Yes
No
Yes
No CLOSE

Customer Contact

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No Customer Contact currently defined
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