DEVICE: coDiagnostiX (D835CDX1)

Device Identifier (DI) Information

coDiagnostiX
9
In Commercial Distribution

Dental Wings GmbH
D835CDX1
HIBCC

1
342721295 *Terms of Use
Dental implant planning software
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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
Diagnostic x-ray digital imaging system workstation A freestanding image processing device typically designed to be a component of an x-ray-based diagnostic digital imaging system [e.g., a digital x-ray system, x-ray computed tomography (CT) system, or fluoroscopy system]; it may sometimes alternatively function as a component of a radiology picture archiving and communication system (PACS). It does not contain the controls for the direct operation of an imaging system but can receive and transmit data both on-line and off-line and is typically located remote from the operator's console. It may have the capability to further process, manipulate and/or view patient images and information collected from other x-ray based imaging systems.
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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 [?]
K130724 000
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Sterilization

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

[?]
Storage and Handling
Special Storage Condition, Specify: Controlled moisture (no condensation)
Storage Environment Atmospheric Pressure: between 12 and 106 KiloPascal
Storage Environment Humidity: between 15 and 85 Percent (%) Relative Humidity
Storage Environment Temperature: between -29 and 60 Degrees Celsius
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Clinically Relevant Size

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

68940839-990a-46e5-a579-b51ab3683d2a
July 06, 2018
3
September 17, 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
D835CDX202 40 D835CDX1 In Commercial Distribution
D835CDX201 20 D835CDX1 In Commercial Distribution
D835CDX200 1 D835CDX1 In Commercial Distribution
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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

[?]
Yes
No
No
Yes
No CLOSE

Customer Contact

[?]
888-856-6997
coDiagnostiX.Support@dental-wings.com
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