(54 days)
K051553, P050014
Not Found
No
The document describes standard PACS workstation functionality and image processing techniques without mentioning AI or ML.
No
The "Intended Use" and "Device Description" sections state that the software is used for processing, viewing, and manipulating medical images, which are diagnostic functions, not therapeutic.
Yes
Explanation: The device is described as "the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed" and for "the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images". This indicates its use in the diagnostic process by a medical professional.
Yes
The device is described as "PACS workstation software" and "an integral component of the Fuji Synapse PACS," which is a software system for managing medical images. While it requires installation on an off-the-shelf PC and interacts with displays, the core medical device functionality described is entirely within the software for processing, viewing, and manipulating medical images. The description focuses on software features and capabilities.
Based on the provided text, 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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The description clearly states that the FUJIFILM Synapse Workstation Software is intended for the processing, viewing, and manipulation of medical images from various imaging modalities (X-ray, CT, MRI, ultrasound, etc.). It acts as a user interface for radiologists and other medical professionals to work with these images.
- No mention of biological samples: There is no mention of the device analyzing or interacting with biological samples from a patient. Its input is medical images, not bodily fluids or tissues.
Therefore, the device falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FUJIFILM Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The FUJIFILM Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The Synapse Workstation may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or noncompressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
The FUJIFILM Synapse Workstation Software Version 3.3.0 is PACS workstation software and an integral component of the Fuji Synapse PACS. Synapse Workstation Software Version 3.3.0, provides processing, viewing and manipulation of radiological data including images, reports, patient status, and clinical information. The workstation utilizes a folder structure oroviding easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individual requirements. The common and basic image manipulation functions such as window/level and window/width variation, magnification, density value, etc., are available for mammography as well as nonmammography images. In addition to common image manipulation functions the Synapse Workstation Software Version 3.3.0 provides image processing sub-systems for processing images from various modality types such as Fuji CR, Fuji MG, CT, along with general image processing for any SOP class image.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, DICOM compliant modalities, DICOM MG "For Processing" images.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
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)
Not Found
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.
K051553, P050014
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
§ 892.2050 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).
0
OCT 17 2011 K112439
FUJKFILM
FUJIFILM MEDICAL SYSTEMS U.S.A., INC.
STAMFORD, CONNECTICUT 06902 PHONE: 203-324-2000 TOLL-FREE: 800-431-1850 FAX: 203-353-0926
510(k) Summary
| Applicant/Submitter Information: | FUJIFILM Medical Systems U.S.A., Inc. |
|---|---|
| 419 West Avenue | |
| Stamford, Connecticut 06902 | |
| Telephone: (301) 251-1092 | |
| Facsimile: (203) 602-3785 | |
| Contact: | Jyh-Shyan Lin |
| Senior Manager of Regulatory, Quality and Clinical Affairs | |
| Date Prepared: | August 22, 2011 |
| Trade/Proprietary Name: | FUJIFILM Synapse Workstation Software Version 3.3.0 |
| Common/Usual Name: | Medical Image Processing Workstation |
| Classification Name: | Picture Archiving and Communications Systems (PACS) |
| Establishment No.: | 2443168 |
| Panel: | Radiology |
| Device Classification: | Class II |
| Product Code: | LLZ |
| Regulation Number: | 21CFR 892.2050 |
| Predicate Device(s): | Fuji Synapse Workstation Software Version 3.1.0 (K051553) |
| Fuji's Computed Radiography Mammography Suite (FCRMS) software (P050014) |
Synapse Workstation Software Version 3.3.0
():
1
Description of Device:
The FUJIFILM Synapse Workstation Software Version 3.3.0 is PACS workstation software and an integral component of the Fuji Synapse PACS. Synapse Workstation Software Version 3.3.0, provides processing, viewing and manipulation of radiological data including images, reports, patient status, and clinical information. The workstation utilizes a folder structure oroviding easy navigation and organization of images, studies, documents, etc. that most users are familiar with from Microsoft Explorer and other Windows applications. The workstation contains workflow scripting and hanging protocols designed to maximize productivity and allow each user to tailor the workstation operation to their individual requirements. The common and basic image manipulation functions such as window/level and window/width variation, magnification, density value, etc., are available for mammography as well as nonmammography images. In addition to common image manipulation functions the Synapse Workstation Software Version 3.3.0 provides image processing sub-systems for processing images from various modality types such as Fuji CR, Fuji MG, CT, along with general image processing for any SOP class image.
Substantial Equivalence:
The FUJIFILM Synapse Workstation Software Version 3.3.0 is substantially equivalent to the predicate devices, Synapse Workstation Software Version 3.1.0 and the MgforProcessing IPSS is the same as that provided by Fuji's Computed Radiography Mammography Suite (FCRMS) software (P050014). The major change is that Version 3.3.0 will now be capable of processing MG images and the indications for use statement has changed slightly from the Synapse Workstation Software Version 3.1.0 IFU to address the fact that Version 3.3.0 will now be able to process DICOM MG images, functionality that was approved in PMA P50014, with the contingency that it may be added to a Fuji review workstation.
Indications for Use:
FUJIFILM Synapse Workstation Software is intended for installation on an off-the-shelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The FUJIFILM Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine, and images from other DICOM compliant modalities.
The Synapse Workstation may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or noncompressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.
2
Safety Information:
The FUJIFILM Synapse Workstation Software Version 3.3.0 introduces no new safety or efficacy issues other than those already identified with the predicate devices. The results of the Hazard Analysis combined with the appropriate preventive measures taken indicate that the device is of moderate level of concern as per the May 11, 2005 issue of the "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".
Conclusion:
This 510(k) premarket notification submission has demonstrated Substantial Equivalence as defined and understood in the Federal Food Drug and Cosmetic Act and various guidance documents issued by the Center for Devices and Radiological Health. We conclude the subject device to be as safe and effective as the predicate devices.
3
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/3/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are connected and form a single, abstract shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.
Food and Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993
Jyh-Shyan Lin, Ph.D. Senior Manager, Regulatory, Quality, and Clinical Affairs FUJIFILM Medical Systems, U.S.A., Inc. 419 West Avenue STAMPFORD CT 06902
MAY 2 2012
Re: K112439
Trade/Device Name: SYNAPSE Picture Archiving and Communications Systems (PACS) Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: August 22, 2011 Received: August 24, 2011
Dear Dr. Lin:
This letter corrects our substantially equivalent letter of October 17, 2011.
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 (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.
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
4
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely Yours,
Michael D'Oker for
Janine M. Morris Acting Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
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Indications for Use
长112439 510(k) Number (if known): __
Device Name: FUJIFILM Synapse Workstation Software Version 3.3.0
Indications for Use:
FUJIFILM Synapse Workstation Software is intended for installation on an off-theshelf PC meeting or exceeding minimum specifications and networked with Fuji Synapse PACS. The FUJIFILM Synapse Workstation is intended to serve as the primary user interface for the processing of medical images for presentation on displays appropriate to the medical task being performed. The Synapse Workstation can process medical images from the following modality types: plane X-ray radiography, X-ray computed tomography, magnetic resonance imaging, ultrasound, nuclear medicine and images from other DICOM compliant modalities.
The Synapse Workstation may be used to process DICOM MG "For Processing" images and also for the display, manipulation, and interpretation of lossless compressed or non-compressed mammography images that have been received in the DICOM For Presentation format and displayed on FDA cleared, DICOM compatible displays for mammography.
Prescription Üse X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Device (OIVD)
Mary Scotts
Division Sign-Off
Division of Radialogical Devi Office of In Vitro Diagnostic Davice Evaluation
510K K112439
Synapse Workstation Software Version 3.3.0
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