DEVICE: syngo X Workplace (04056869010120)

Device Identifier (DI) Information

syngo X Workplace
10281299
In Commercial Distribution

Siemens Healthcare GmbH
04056869010120
GS1

1
313217003 *Terms of Use
No description.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
No
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
Diagnostic x-ray digital imaging system workstation A freestanding component of an x-ray-based diagnostic digital imaging assembly [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system] designed to process patient radiological images; it may additionally be intended to be integrated as part of a radiology picture archiving and communication system (PACS). It consists of dedicated hardware (e.g., computer processing unit, monitor) with integrated software typically to assist image analysis (e.g., viewing, manipulation, interpretation); it does not include controls for direct operation of the imaging system.
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FDA Product Code

[?]
Product Code Product Code Name
LLZ System, image processing, radiological
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
K042995 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 10 and 35 Degrees Celsius
Handling Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity
Storage Environment Temperature: between -20 and 60 Degrees Celsius
Special Storage Condition, Specify: Not Condensing
Handling Environment Humidity: between 20 and 80 Percent (%) Relative Humidity
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
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Clinically Relevant Size

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

f71ab9b3-5840-465e-9ff4-a6a9e2b7481b
February 21, 2019
4
September 24, 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
No
No CLOSE

Customer Contact

[?]
+1(800)888-7436
XX@XX.XX
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