DEVICE: FCRView (04547410316926)

Device Identifier (DI) Information

FCRView
CR-VW674
In Commercial Distribution

FUJIFILM CORPORATION
04547410316926
GS1

1
713565195 *Terms of Use
FCRView (CR-VW 674) is a Workstation intended to associate FCR images with patient and exam information, apply images processing to facilitate diagnosis, display the images, and output the resulting image and exam data for further display, distribution, or archiving. In addition, the FCR View can receive DICOM multi modality images for viewing. The FCR View must not be used for primary diagnosis of mammography images.
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Device Characteristics

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

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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
No CLOSE

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

ee1a0427-c6ce-470f-afdb-34416fce3dd7
March 29, 2018
2
September 16, 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
No
No
No CLOSE

Customer Contact

[?]
+018002728465
xxx@xxx.xxx
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