DEVICE: ResolutionMD® (B037RESMDC0)

Device Identifier (DI) Information

ResolutionMD®
RESMD-C
In Commercial Distribution

Calgary Scientific Inc
B037RESMDC0
HIBCC

1
240398698 *Terms of Use
ResolutionMD® software is an enterprise medical image viewer used with off-the-shelf servers, web browsers, and specific mobile devices for the 2D display, Multi-planar reformatting and 3D visualization of medical image data and reports. It provides collaboration and integrated secure audio-video communication, and displays DICOM and non-DICOM medical images and reports.
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Device Characteristics

Labeling does not contain MRI Safety Information
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No
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Yes
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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 program or group of programs, routines or algorithms that add specific computer assisted display, processing and/or analysis capabilities to picture archiving and communication system (PACS) used for radiology. A basic set of applications programs and routines are included with such a PACS and can be upgraded to correct programming errors or to add new system capabilities. Applications program packages are typically identified by a proprietary name and "version" or "upgrade" number.
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FDA Product Code

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Product Code Product Code Name
LLZ System, Image Processing, Radiological
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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

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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

9db51d0b-b144-48c7-94eb-974280192752
March 29, 2018
2
December 23, 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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Yes
No
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No CLOSE

Customer Contact

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No Customer Contact currently defined
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