(190 days)
Not Found
No
The description details modifications to existing image processing algorithms (EDR and MFP) using feature recognition and low-frequency tables, which are traditional image processing techniques, not explicitly AI/ML methods. There is no mention of training data, neural networks, or machine learning models.
No.
The device is an optional software for an X-ray system, intended to optimize image quality. It does not provide any therapy or treatment.
No
Explanation: The device is described as image processing software that optimizes image quality for X-ray images, not for making a diagnosis.
No
The device description explicitly states that Dynamic Visualization II Image Processing is "optional software included in v9.0 of the FDX Console," and the FDX Console is part of the "Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600)," which is described as a "portable digital detector system" that includes hardware components like a flat panel detector. While the submission focuses on the software, the device as a whole is a system that includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to detect diseases, conditions, or infections.
- Device Function: The described device is a software component for an X-ray system. Its purpose is to process and optimize radiographic images acquired from a patient's body. It does not perform any tests on biological samples.
- Intended Use: The intended use clearly states it's for "providing optimized image quality over a wide range of patient thicknesses," which is related to medical imaging, not in vitro testing.
Therefore, the Dynamic Visualization II Image Processing software is a component of a medical imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use.
Product codes (comma separated list FDA assigned to the subject device)
MQB
Device Description
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic svstems. The FDR D-EVO is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. The Acquisition Workstation for the DR-ID600 is the FDX Console. Dynamic Visualization II Image Processing (DVII) is optional software included in v9.0 of the FDX Console. The FDX Console and Dynamic Visualization II software may be used with Fujifilm DR and CR X-ray systems.
Dynamic Visualization II is an enhanced version of Fujifilm's Dynamic Visualization™ (DV) image processing software. The enhancements made to DVII are designed to provide optimized image quality over a wide range of patient thicknesses, and can be particularly useful when imaging bariatric patients.
DVII uses the same image processing sequence as the predicate DV, but the EDR (Exposure Data Recognition) and MFP (Multi-objective Frequency Processing) algorithms have been modified. When compared to the current EDR and MFP algorithms, the corresponding new algorithms (EDR2, MFP2) have been modified as follows:
EDR2 - to identify and optimize various anatomic structures in an acquired image prior to the subsequent application of contrast and sharpness image processing steps, EDR2 uses a feature recognition method as opposed to conventional EDR's histogram analysis method.
MFP2 - similar to MFP, MFP2 sharpens and balances contrast in anatomic structures in an image after being subject to Exposure Data Recognition. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
x-ray
Anatomical Site
human anatomy
Indicated Patient Age Range
adults, pediatrics and neonates
Intended User / Care Setting
Not Found
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 conformity to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM remains unaffected. As required by the risk analysis, all verification and validation activities related to the improvements made to the Dynamic Visualization II Image Processing Option were performed and the results were satisfactory.
FUJIFILM conducted a comparative image quality evaluation between the predicate device Dynamic Visualization (DV) and the proposed modified device, Dynamic Visualization II (DV2). Raw clinical images were processed with the predicate image processing algorithms (DV), and then the raw images were processed using the proposed image processing algorithms (DV2). Randomized image pairs (DV vs. DV2) were then evaluated by three readers. Slightly more than half of the images were of bariatric patients. The results of the evaluation demonstrates that DV2 optimizes image quality for all patients, even when images of larger patients are processed using the proposed, modified device.
Clinical Performance Data: The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical 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.
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
§ 892.1680 Stationary x-ray system.
(a)
Identification. A stationary x-ray system is a permanently installed diagnostic system intended to generate and control x-rays for examination of various anatomical regions. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A radiographic contrast tray or radiology diagnostic kit intended for use with a stationary x-ray system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
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" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 31, 2017
FUJIFILM Medical Systems U.S.A., Inc. % Dharaben Desai Sr. Regulatory Affairs Specialist 419 West Avenue STAMFORT CT 06902
Re: K163624
Trade/Device Name: Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600) Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: MQB Dated: May 23, 2017 Received: May 24, 2017
Dear Dharaben Desai:
This letter corrects our substantially equivalent letter of June 30th, 2017. 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/ResourcesforYou/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,
Robert Ocks
Robert Ochs, Ph.D. Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600).
Indications for Use (Describe)
Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use.
Type of Use (Select one or both, as applicable)
2 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:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) Summary
Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of DR-ID600)
Date: May 23, 2017
Submitter's Information:
FUJIFILM Medical Systems U.S.A., Inc. 419 West Avenue Stamford, CT, 06902, USA
Contact Person:
| Name: | Dharaben Desai |
|---|---|
| Title: | Sr. Regulatory Affairs Specialist |
| Telephone: | (203) 276-3445 |
| Facsimile: | (203) 602-3785 |
Identification of the Device:
| Proprietary/Trade Name: | Dynamic Visualization II Image Processing Option
for the FDX Console (DR-ID300CL of DR-ID600) |
|-------------------------|--------------------------------------------------------------------------------------------------|
| Classification Name: | Stationary X-ray system |
| Regulations Number: | 21 CFR 892.1680 |
| Product Codes: | MQB |
| Device Class: | Class II |
| Review Panel: | Radiology |
| Common Name: | Flat Panel Digital Detector System |
Identification of the Legally Marketed Predicate Device:
FDR D-EVO Flat Panel Detector System (DR-ID600) with Improved Virtual Grid Software, K153464 cleared 4/8/2016
l. DEVICE DESCRIPTION
Fujifilm's FDR D-EVO Flat Panel Detector System (DR-ID600) is a portable digital detector system that interfaces with, and acquires and digitizes x-ray exposures, from standard radiographic svstems. The FDR D-EVO is designed to be used in any environment that would typically use a radiographic cassette for examinations of adults, pediatrics and neonates. The detector models support both wireless and wired/tethered data communication between the detector and the system. Detectors can be placed in a wall bucky for upright exams, a table bucky for recumbent exams, or removed from the bucky for non-grid exams. The Acquisition Workstation for the DR-ID600 is the FDX Console. Dynamic Visualization II Image Processing (DVII) is optional software included in v9.0 of the FDX Console. The FDX Console and Dynamic Visualization II software may be used with Fujifilm DR and CR X-ray systems.
4
Dynamic Visualization II is an enhanced version of Fujifilm's Dynamic Visualization™ (DV) image processing software. The enhancements made to DVII are designed to provide optimized image quality over a wide range of patient thicknesses, and can be particularly useful when imaging bariatric patients.
DVII uses the same image processing sequence as the predicate DV, but the EDR (Exposure Data Recognition) and MFP (Multi-objective Frequency Processing) algorithms have been modified. When compared to the current EDR and MFP algorithms, the corresponding new algorithms (EDR2, MFP2) have been modified as follows:
EDR2 - to identify and optimize various anatomic structures in an acquired image prior to the subsequent application of contrast and sharpness image processing steps, EDR2 uses a feature recognition method as opposed to conventional EDR's histogram analysis method.
MFP2 - similar to MFP, MFP2 sharpens and balances contrast in anatomic structures in an image after being subject to Exposure Data Recognition. MFP2 uses additional low frequency tables and a combination of automatic and preset dynamic range control operations.
II. INDICATIONS FOR USE
Dynamic Visualization II Image Processing is an optional software for the FDX Console, intended to provide optimized image quality over a wide range of patient thicknesses, especially for bariatric imaging. The device is not intended for mammography use.
. SUMMARY OF TECHNOLOGICAL CHARACTERISTICS
FDR D-EVO FPD System (DR-ID600) continues to offer 600 series detectors with two different scintillator materials - GOS (Gadolinium oxysulfide) or Csl (Cesium lodide) - and various detector sizes to choose from. All detector characteristics including indirect conversion method using Fujifilm's unique Irradiated Side Sampling (ISS) technology, pixel pitch (150µm), resolution (16 bit), DQE (Detective Quantum Efficiency) measurements, MTF (Modulation Transfer Function) performance remains the same. The wireless communication feature, and automatic x-ray detection function (known as 'SmartSwitch' in the US) also stay unaffected by the changes. The same acquisition workstation, FDX Console will continue to support FDR D-EVO FPD System (DR-ID600). FDX Console v9.0 or later will release the Dynamic Visualization II Image Processing Option for the FDX Console (DR-ID300CL of the DR-ID600).
| | Subject/Modified Device
Dynamic Visualization II Image
Processing Option for the FDX
Console (DR-ID300CL of the DR-
ID600) | 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) |
|-------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use
of the DR D-EVO
FPD system DR-
ID600 | The Wireless/Wired FDR D-EVO flat
panel detector system is intended to
capture for display radiographic
images of human anatomy. It is | The Wireless/Wired FDR D-EVO flat
panel detector system is intended to
capture for display radiographic
images of human anatomy. It is |
| | Subject/Modified Device | Predicate Device |
| | Dynamic Visualization II Image
Processing Option for the FDX
Console (DR-ID300CL of the DR-
ID600) | FDX Console (DR-ID300CL) With
Virtual Grid Software Option
for the FDR D-EVO FPD system (DR-
ID600)
(K153464 cleared 4/8/2016) |
| (unchanged) | 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. | 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. |
| Indications for use
for option | Dynamic Visualization II Image
Processing is an optional software
for the FDX Console, intended to
provide optimized image quality over
a wide range of patient thicknesses,
especially for bariatric imaging. The
device is not intended for
mammography use. | 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. |
| Option for | Same as Predicate | FDX Console of the Wireless/Wired
FDR D-EVO flat panel detector
system DR-ID600 |
| | Image Processing Characteristics | |
| Dynamic
Visualization
Algorithm | DV II uses a combination of EDR2
and MFP2 | DV uses a combination of EDR and
MFP |
| Exposure Data
Recognizer
Algorithm (EDR) | EDR2- to identify and optimize
various anatomic structures in an
acquired image prior to the
subsequent application MFP2
processing, EDR2 uses a feature
recognition method to identify
direct x-ray, bone, tissue, and
artificial object regions | EDR- uses the conventional histogram
analysis method prior to the
subsequent application MFP
processing. |
| Frequency Noise
Control (FNC) | Same as Predicate | Performs noise suppression |
| Multi objective
Frequency
Processing (MFP) | MFP2 performs Spatial Frequency
Enhancement and Dynamic
Range Control similar to that of
MFP, but with two new lower
frequency bands and automated
Dynamic Range Control Features. | MFP performs Spatial Frequency
Enhancement and Dynamic Range
Control using six frequency bands and
fixed Dynamic Range Control
Features. |
| Gradation
Processing (Gp) | Same | Performs global brightness and
contrast adjustment following MFP
processing. |
| | Miscellaneous | |
| Available flat panel
detectors | Same | Same |
| Detector Wireless
Features | Same | Same |
| | Subject/Modified Device | Predicate Device |
| | Dynamic Visualization II Image
Processing Option for the FDX
Console (DR-ID300CL of the DR-
ID600) | FDX Console (DR-ID300CL) With
Virtual Grid Software Option
for the FDR D-EVO FPD system (DR-
ID600)
(K153464 cleared 4/8/2016) |
| Auto X-ray detection
feature | Same | Same |
| Workstation
Software Version | Same as Predicate | FDX Console Version 9.0 |
| 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 optional) Monitor.
Accessories: Keyboard, Mouse,
Barcode scanner | 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 |
| Operating System | Windows 7 Professional 32-bit | Windows Vista/Windows 7
Professional 32-bit |
| Image Transfer | Same as Predicate | Standard network connectivity via
DICOM protocol & via Fuji DMS
Network |
5
6
IV. SUBSTANTIAL EQUIVALENCE
The FDR D-EVO FPD System (DR-ID600) with the Dynamic Visualization II Image Processing Option is substantially equivalent to the following legally marketed device:
| Legally Marketed Device | 510(k) # | Clearance Date |
|---|---|---|
| FDR D-EVO Flat Panel Detector System (DR-ID600) | ||
| with Improved Virtual Grid Software | K153464 | 4/8/2016 |
The FDX Console version 9.0 software was cleared with the FDR D-EVO FPD System (DR-ID600) in K153464. The FDR D-EVO's detector characteristics as well as other maior features such as wireless communication and automatic x-rav detection function ('SmartSwitch') remain unchanged. The FDR D-EVO can be used with or without the Dynamic Visualization II Image Processing Option, and the improvements do not affect the intended use or alter the fundamental scientific technology of the legally marketed device. The only change between the predicate device and the proposed device of this submission is the addition of the Dynamic Visualization II Image Processing Option, which is an improvement of the Dynamic Visualization option available with the predicate device.
V. SUMMARY OF STUDIES
Non-clinical Performance Data: The conformity to the voluntary standards such as AAMI/ANSI ES60601-1, IEC 60601-1, IEC 60601-1-2, IEC 62304, IEC 62366, IEC 62494-1 and DICOM remains unaffected. As required by the risk analysis, all verification and validation activities related to the improvements made to the
7
Dynamic Visualization II Image Processing Option were performed and the results were satisfactory.
FUJIFILM conducted a comparative image quality evaluation between the predicate device Dynamic Visualization (DV) and the proposed modified device, Dynamic Visualization II (DV2). Raw clinical images were processed with the predicate image processing algorithms (DV), and then the raw images were processed using the proposed image processing algorithms (DV2). Randomized image pairs (DV vs. DV2) were then evaluated by three readers. Slightly more than half of the images were of bariatric patients. The results of the evaluation demonstrates that DV2 optimizes image quality for all patients, even when images of larger patients are processed using the proposed, modified device.
Clinical Performance Data: The changes do not require clinical studies. The substantial equivalence has been demonstrated by non-clinical studies.
VI. CONCLUSION
Based upon the supporting data summarized above. FMSU concludes the Dynamic Visualization II Image Processing Option offered with FDR D-EVO Flat Panel Detector System (DR-ID600) is as safe and effective as the legally marketed device K153464 and does not raise different questions of safety and effectiveness than K153464.