DEVICE: Dornier MedTech (04049957005566)

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Device Record History
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Device Identifier (DI) Information
Dornier MedTech
Genesis
In Commercial Distribution
K1041701
Dornier MedTech GmbH
04049957005566
GS1

1
388104085 *Terms of Use
Genesis Urology Imaging System, Left, UV, FPD, 80 KW, 480 V
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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?
37633 Stationary uro-gynaecological fluoroscopic x-ray system, digital
A stationary diagnostic x-ray system with real-time fluoroscopic capabilities specifically designed for use in urological and/or gynaecological surgical and interventional procedures requiring real-time visualization of the pelvic area. It uses digital techniques for real-time image capture, display and manipulation and include spot-film capabilities as well as fluoroscopic features. It is commonly used for imaging and x-ray guided surgical or interventional procedures. The images can be viewed in both real-time and delayed formats and may include various levels of imaging processing and analysis capabilities.
Active false
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FDA Product Code

[?]
Product Code Product Code Name
JAA System, X-Ray, Fluoroscopic, Image-Intensified
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FDA Premarket Submission
FDA Premarket Submission Number [?] Supplement Number [?]
K122768 000
No CLOSE

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

[?]
Size Type Text
No Device Sizes
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Device Record Status
dba30b92-db25-4732-92ea-78e585fdd228
February 06, 2024
2
September 13, 2018
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Alternative and Additional Identifiers Additional Identifiers

Package DI

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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)

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

[?]
No
Yes
No
Yes
No CLOSE

Customer Contact

[?]
No Customer Contact currently defined
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