Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard image processing and data management functionalities typical of a radiology workstation, with no mention of AI, ML, or related concepts.

Therapeutic

No
The device is a workstation for image processing and management, not for treating or diagnosing medical conditions.

Diagnostic

No

The "Intended Use / Indications for Use" states that the device applies image processing "to facilitate diagnosis," but the "Device Description" clarifies that it is used by a radiographer for "quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer." This indicates that the device assists in the preparation and display of images, but the diagnosis itself is performed elsewhere.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "workstation" and is used by a radiographer for viewing images and connecting to "Fuji Image Readers via a network," implying it includes hardware components beyond just software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, or tissue) to detect diseases, conditions, or infections.
Device Function: The FDX Console is a workstation that processes and displays medical images (CR and DR) for the purpose of facilitating diagnosis by a radiographer. It works with images generated from external imaging equipment, not with biological samples.
Intended Use: The intended use clearly states it's for associating digital images with patient information, applying image processing, displaying images, and outputting data. This is related to medical imaging, not in vitro testing.
Device Description: The description reinforces its role in viewing, processing, and transferring medical images.
Lack of IVD-related information: There is no mention of analyzing biological samples, detecting biomarkers, or any other activity typically associated with IVD devices.

Therefore, the FDX Console falls under the category of medical imaging software/workstations, not In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.

Product codes

LLZ

Device Description

The FDX Console is used by a radiographer for viewing Digital Radiography (DR) and Computed Radiography (CR) images for final quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer. Furthermore, when connected to Fuji Image Readers via a network, the FDX Console is used to enter patient ID information, exposure information, and in the case of CR register Image Plate (IP) barcode numbers. The FDX Console is compatible with the ACR/NEMA DICOM Version 3.0 standard.

The four primary features of the FDX Console are patient identification, exam selection, image processing, and image transmission.

Patient Identification feature: Patient demographics can be manually . entered using a keyboard or captured from a RIS/HIS using DICOM Worklist Management. Also, a Touch screen monitor and barcode reader streamlines this data entry.
Exam Selection feature: Select the patient, select the applicable exam, for CR barcode the Imaging Plate (IP), and touch Start to select the exam or use the DICOM Worklist Management feature with Auto Exam Select.
. Image Processing feature: DR and CR Images are processed, displayed and reviewed prior to image transfer.
Image Transmission feature: Images are transferred to other medical imaging devices for softcopy viewing or storage devices for archiving or to a printer for hardcopy film output.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Digital Radiography (DR), Computed Radiography (CR)

Anatomical Site

Human anatomy, generally (excluding mammography)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Radiographer, medical imaging devices for softcopy viewing or storage devices for archiving or to a printer for hardcopy film output.

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Non-clinical Performance Data: The FDX Console conforms to the following voluntary standards:

DICOM, V3.0 2007: Digital Imaging and Communications in Medicine (DICOM)
IEC 62304: 2006: Medical Device Software – Software Life Cycle Processes
IEC 62366: 2014: Medical devices – Application of usability engineering to medical devices

As required by the risk analysis, all verification and validation activities related to the FDX Console were performed and the results were satisfactory. The verification and validation results are provided in the submission.

Clinical Performance Data: Clinical studies were not required as there is no change in image processing. The substantial equivalence has been demonstrated by nonclinical studies.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K041990, K153464

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

Regulation Number and Section

§ 892.2050 Medical image management and processing system.

(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, with flowing lines extending from the bottom profile.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

March 16, 2017

FUJIFILM Medical Systems USA, Inc. % Mr. Peter Altman Regulatory and Quality Consultant 419 West Avenue STAMFORD CT 06902

Re: K170451

Trade/Device Name: FDX Console (DR-ID300CL) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: February 8, 2017 Received: February 15, 2017

Dear Mr. Altman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

1

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Michael O'Hara

For

Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K170451

Device Name FDX Console (DR-ID300CL) Software

Indications for Use (Describe)

The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)

PLEASE DO NOT WRITE BELOW THIS LINE = CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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See PRA Statement below.

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Image /page/3/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with a red square above the "I" in "FUJIFILM". Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's commitment to providing value through innovation.

510(k) Summary

FDX Console (DR-ID300CL) Software

Date: February 8, 2017

Submitter's Information:

FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA

Contact Person:

Name:	Peter Altman
Title:	Regulatory and Quality Consultant
Telephone:	(203) 602-3576
Facsimile:	(203) 602-3785

Identification of the Device:

Proprietary/Trade Name:	FDX Console (DR-ID300CL) Software
Classification Name:	Picture Archiving and Communications System
Regulations Number:	21 CFR 892.2050
Product Codes:	LLZ
Device Class:	Class II
Review Panel:	Radiology
Common Name:	Medical	Image	Processing	Workstation or Acquisition Workstation

Identification of the Legally Marketed Predicate Devices:

1. FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016
1. Fuji Medical CR Console, K041990, cleared 8/6/2004

DEVICE DESCRIPTION l.

The FDX Console is used by a radiographer for viewing Digital Radiography (DR) and Computed Radiography (CR) images for final quality assurance (QA) checking and image processing and optimization prior to transferring the images to external devices such as a PACS or a printer. Furthermore, when connected to Fuji Image Readers via a network, the FDX Console is used to enter patient ID information, exposure information, and in the case of CR register Image Plate (IP) barcode numbers. The FDX Console is compatible with the ACR/NEMA DICOM Version 3.0 standard.

The four primary features of the FDX Console are patient identification, exam selection, image processing, and image transmission.

4

Image /page/4/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in a bold, sans-serif font, with a red square above the "I" in "FUJIFILM". Below the logo is the tagline "Value from Innovation" in a smaller, sans-serif font. The logo is simple and modern, and the tagline conveys the company's commitment to innovation.

Patient Identification feature: Patient demographics can be manually . entered using a keyboard or captured from a RIS/HIS using DICOM Worklist Management. Also, a Touch screen monitor and barcode reader streamlines this data entry.
Exam Selection feature: Select the patient, select the applicable exam, for CR barcode the Imaging Plate (IP), and touch Start to select the exam or use the DICOM Worklist Management feature with Auto Exam Select.
. Image Processing feature: DR and CR Images are processed, displayed and reviewed prior to image transfer.
Image Transmission feature: Images are transferred to other medical imaging devices for softcopy viewing or storage devices for archiving or to a printer for hardcopy film output.

INDICATIONS FOR USE ..............................................................................................................................................................................

The FDX Console is a workstation intended to associate digital (CR and/or DR) images with patient and exam information, apply image processing to facilitate diagnosis, display the image, and output the resulting image and exam data for further display, distribution, or archiving. The FDX Console is not for use in Mammography.

SUMMARY OF TECHNOLOGICAL CHARACTERISTICS .

The FDX Console is a software device based upon the predicate devices. The modifications implemented in Version 10.0 do not alter the technological characteristics of the predicates, i.e., software is installed on off-the-shelf computer hardware running Microsoft Windows operating systems.

SUBSTANTIAL EQUIVALENCE IV.

The FDX Console Version 10.0 Software is substantially equivalent to the following legally marketed device:

Legally Marketed Device	510(k) #	Clearance Date
Fuji Medical CR Console Model Flash IIP	K041990	8/6/2004
FDR D-EVO FPD System (DR-ID600) (includes the
FDX Console Version 9.0 software)	K153464	4/8/2016

The CR Console has been chosen as the predicate device because it is the FDX Console's predecessor and therefore the general design including software, GUI, features, and capabilities are extremely similar. One of the major differences is that the FDX Console has the capability to acquire and process images from all Fujifilm digital radiography system whereas the CR Console was limited to Computed Radiography only.

The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. It has exactly the same image processing software as the subject Version 10.0 device. The only differences are that FDX Console V10.0 will be able to use the Microsoft Windows 10 operating

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Image /page/5/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller font.

system and that this submission introduces the SmartController and RemoteDesktop software capabilities allowing remote operation of the FDX Console. The following comparison applies:

	Subject Device	Predicate Device	Predicate Device
	FDX Console (DR-
ID300CL) Software	FDX Console (DR-
ID300CL) With Virtual Grid
Software Option
for the FDR D-EVO FPD
system (DR-ID600)
(K153464 cleared
4/8/2016)	Fuji CR Console (Flash
IIP)
(K041990 cleared
8/6/2004)
Indications
for Use
Indications
for use for
options	The FDX Console is a
workstation intended to
associate digital (CR
and/or DR) images with
patient and exam
information, apply image
processing to facilitate
diagnosis, display the
image, and output the
resulting image and
exam data for further
display, distribution, or
archiving. The FDX
Console is not for use in
Mammography.	The Wireless/Wired FDR D-
EVO flat panel detector
system is intended to capture
for display radiographic
images of human anatomy. It
is intended for use in general
projection radiographic
applications including
pediatric and neonatal exams
wherever conventional film
/screen or CR systems may
be used. The FDR D-EVO is
not intended for
mammography, fluoroscopy,
tomography, and angiography
applications.
The FDR D-EVO can be used
with Virtual Grid Software,
which is optional image
processing software installed
on Fujifilm's FDX Console.
Virtual Grid Software can be
used in lieu of an anti-scatter
grid to improve image
contrast in general
radiographic images by
reducing the effects of scatter
radiation.	The Fuji CR Console is a
CR modality workstation
intended to associate digital
FCR images (except
mammography images)
with patient and exam
information, apply image
processing to facilitate
diagnosis, display the
image, and output the
resulting image and exam
data for further display,
distribution, or archiving.
None.
	None.
		Image Processing Characteristics
Spatial
Frequency
Processing	Yes	Yes	Yes
Tonal
Conversion	Yes	Yes	Yes
Dynamic Range
Control
Processing
(DRC)	Yes	Yes	Yes
Tomographic
Artifact
Suppression
Processing
(TAS)	Yes	Yes	Yes
Gradation
Processing	Yes	Yes	Yes
Multi-Objective
Frequency
Processing	Yes	Yes	Yes
	Subject Device	Predicate Device	Predicate Device
	FDX Console (DR-
ID300CL) Software	FDX Console (DR-
ID300CL) With Virtual Grid
Software Option
for the FDR D-EVO FPD
system (DR-ID600)
(K153464 cleared
4/8/2016)	Fuji CR Console (Flash
IIP)
(K041990 cleared
8/6/2004)
(MFP)
Flexible Noise
Control (FNC)	Yes	Yes	Yes
Grid Pattern
Removal (GPR)	Yes	Yes	Yes
Image
Automatic
Composition
Processing
(Image
Stitching)	Yes	Yes	Yes
CoRrection
Filter (CRF)	Yes	Yes	No
Image
processing
without
normalization	Yes	Yes	No
Tomosynthesis
Option	Yes	Yes	No
Dual Energy
Subtraction(DE
S) Option	Yes	Yes	No
Virtual Grid
Option	Yes	Yes	No
Improved
Virtual Grid
Software (VG2)	Yes	Yes	No
Miscellaneous
Workstation
Software
Version	10.0	9.0	A11
Transfer
images to
PACS	Yes	Yes	Yes
Enter Patient
info manually	Yes	Yes	Yes
Enter Patient
info from RIS	Yes	Yes	Yes
Select Exam	Yes	Yes	Yes
Minimum
Basic
Computer
Configuration
(as provided in
US)	Model: HP ProDesk
600 G2 Series Small
Form Factor PC
Processor: Intel Core
i5-6500 with 3.2GHz
RAM: 4GB (4x1GB)
Hard Drive: 500GB
CD/DVD: Slim
SuperMulti DVD drive
Display: 17 " or 21"
color (touchscreen)	Model: Mini Tower
Processor: Core 2 Duo
RAM: 2GB
Hard Drive: 80GB
CD/DVD: DVD drive
Display: 17 " or 21" color
(touchscreen optional)
Monitor.
Accessories: Keyboard,
Mouse, Barcode scanner	Model:DELL Optiplex
GX260
Processor: Pentium 4,
3.06GHz
Hard Drive: 40GB
RAM: 512MB
Display: 17 " or 21" color
(touchscreen optional)
Monitor.
	Subject Device
FDX Console (DR-ID300CL) Software	Predicate Device
FDX Console (DR-ID300CL) With Virtual Grid
Software Option
for the FDR D-EVO FPD
system (DR-ID600)
(K153464 cleared
4/8/2016)	Predicate Device
Fuji CR Console (Flash IIP)
(K041990 cleared
8/6/2004)
	optional) Monitor.
Accessories:
Keyboard, Mouse,
Barcode scanner
Operating
System	Windows 10/Windows
7 Professional 32-bit	Windows Vista/Windows 7
Professional 32-bit	Windows 2000
Professional
Image
Transfer	Same as Predicates	Standard network
connectivity via DICOM
protocol & via Fuji DMS
Network	Standard network
connectivity via DICOM
protocol & via Fuji DMS
Network
Remote
Operation
Capability of
Console	SmartController and
Remote Desktop	None	None

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Image /page/6/Picture/0 description: The image shows the Fujifilm logo. The logo consists of the word "FUJIFILM" in bold, black letters, with a red square above the "I". Below the word is the tagline "Value from Innovation" in a smaller font. The logo is simple and modern, and the tagline suggests that Fujifilm is a company that values innovation.

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Image /page/7/Picture/0 description: The image shows the Fujifilm logo. The logo is black, except for a small red square above the "I" in Fujifilm. Below the logo, the words "Value from Innovation" are written in a smaller, black font.

V. SUMMARY OF STUDIES

Non-clinical Performance Data: The FDX Console conforms to the following voluntary standards:

Standard	Title
DICOM, V3.0 2007	Digital Imaging and Communications in
Medicine (DICOM)
IEC 62304: 2006	Medical Device Software – Software Life
Cycle Processes
IEC 62366: 2014	Medical devices – Application of usability
engineering to medical devices

As required by the risk analysis, all verification and validation activities related to the FDX Console were performed and the results were satisfactory. The verification and validation results are provided in the submission.

Clinical Performance Data: Clinical studies were not required as there is no change in image processing. The substantial equivalence has been demonstrated by nonclinical studies.

VI. CONCLUSION

Based upon the supporting data summarized above, we concluded the FDX Console (DR-ID300CL) Software is as safe and effective as the legally marketed devices K041990 andK153464 and does not raise different questions of safety and effectiveness than the predicate devices.