DEVICE: V3D-Calcium Scoring (B209CAS2X10)

Device Identifier (DI) Information

V3D-Calcium Scoring
2.1
In Commercial Distribution

VIATRONIX INCORPORATED
B209CAS2X10
HIBCC

1
017608345 *Terms of Use
V3D-Calcium Scoring is a software application used with advanced PC hardware for coronary artery calcification scoring. It is designed to utilize DICOM 3.0 compliant medical images derived from gated CT heart scan without the use of any contrast agent.
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Device Characteristics

Labeling does not contain MRI Safety Information
No
No
No
Yes
No
No
No
No

GMDN

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GMDN Names and Definitions: © Copyright GMDN Agency 2015. Reproduced with Permission from the GMDN Agency.

GMDN Preferred Term Name GMDN Definition
Radiology picture archiving and communication system application software An individual software application intended to be installed on a central server as part of a picture archiving and communication system (PACS) to allow storage, retrieval, analysis, and management of radiological images. It is designed specifically for use within radiology.
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FDA Product Code

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Product Code Product Code Name
JAK System, X-Ray, Tomography, Computed
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FDA Premarket Submission

FDA Premarket Submission Number [?] Supplement Number [?]
Premarket Submission Number Not Available/Not Released
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Sterilization

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

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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

beb3330e-921d-4aad-a113-6b50eaa0dd7e
September 24, 2018
3
June 17, 2016
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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)

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No
No
None
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Production Identifier(s) in UDI

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No
No
No
Yes
No CLOSE

Customer Contact

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(631) 771-1801
csdsupport@viatronix.com
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