(256 days)
No
The document describes a standard PACS system for image management and viewing, with no mention of AI or ML capabilities.
No.
The device is described as medical image management software used for viewing, storing, processing, and displaying medical images, which aids in diagnosis and pre-operative planning rather than directly treating or preventing a disease or condition.
Yes
The device enables users to overlay templates for pre-operative planning and add annotations and measurements to aid in diagnosis, indicating its role in the diagnostic process. Additionally, the device description states it delivers "enterprise-wide diagnostic images and patient reports, available for review," further solidifying its diagnostic function.
Yes
The device description explicitly states that the device is "constructed from the four software elements" and refers to it as a "software solution." There is no mention of accompanying hardware components that are part of the device itself.
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, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The IPACS Medical Image Management Software is designed for managing, viewing, processing, and archiving medical images obtained from various imaging modalities (CT, MR, US, etc.). It works with images generated by the body, not with samples taken from the body.
- Intended Use: The intended use clearly states it's for "viewing medical images" and managing the associated data. There is no mention of analyzing biological samples.
Therefore, the function and intended use of this software fall outside the scope of an In Vitro Diagnostic device. It is a medical image management and viewing system.
N/A
Intended Use / Indications for Use
IPACS Medical Image Management Software is used for viewing medical images.
IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.
IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on aid in pre-operative planning and annotations and measurements to aid in diagnosis.
Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
Product codes
LLZ
Device Description
The Visbion IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software is a vendor-neutral PACS (Picture Archiving and Communication System) solution delivering enterprise-wide diagnostic images and patient reports, available for review at any time, from any location using a standard web browser.
IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).
Using a standard web browser registered users have the ability to log in thus provide secure access to images from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities. 24 hours a day.
The device is constructed from the four software elements. These elements are combined according to the configuration required by the user. These terms are used by the user, IPACs being a general term to consolidate the following four elements:
Image Archive
lmage Viewer
Image Web
Image Importer
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources.
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
Can be used from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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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 is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles a stylized eagle or bird in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 12, 2014
Visbion Limited % Mr. Thomas Falcon Regulatory Manager Visbion House, Gogmore Lane Chertsey, Surrey KP16 9AP UNITED KINGDOM
Re: K140797
Trade/Device Name: IPACS Medical Image Management Software Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: November 13, 2014 Received: November 17, 2014
Dear Mr. Falcon:
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,
Robert A Ochs
for
Janine M. Morris Director Division of Radiological Health Office of In Vitro Diagnostics and Radiological Health Center for Devices and Radiological Health
Enclosure
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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.
510(k) Number (if known) K140797
Device Name
IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software.
Indications for Use (Describe)
IPACS Medical Image Management Software is used for viewing medical images.
IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.
IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on aid in pre-operative planning and annotations and measurements to aid in diagnosis.
Typical users of IPACS Medical Imagement Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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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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"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."
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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014
Revised 510(k) Summary of Safety and Effectiveness
(in accordance with 21 CFR 807.87(h) and 21 CFR 807.92)
1. Submitter's name and address:
Visbion Ltd Visbion House Gogmore Lane Chertsey, Surrey KT16 9AP United Kingdom
FDA Establishment Registration No. - To be applied for after marketing clearance is given.
2. Submitter's telephone number and fax number: Tel: 011 44 870 850 3486 Fax: 011 44 870 850 3487
3. Contact person: Mr. Tom Falcon - Requlatory Manager and FDA Official Correspondent
- Date this 510(k) summary prepared: ব December 12, 2014
-
- Trade/proprietary name of the device: IPACS Medical Image Management Software
-
- Classification name and number of the device: FDA Class - II FDA Classification Name - Picture Archiving and Communications System (PACS) FDA Regulation Number - 21 CFR 892.2050
-
- Legally marketed predicate device to which substantial equivalence is claimed:
eFilm Workstation with Modules: FDA 510(k) No: K020995 Clearance to market this device was given by FDA on April 12, 2002 FDA Device Classification: Class 2 FDA Regulation Number: 21 CFR 892.2050 FDA Product Code: LLZ
8. Description of the device that is the subject of this premarket notification:
The Visbion IPACS (Integrated Picture Archiving and Communications System) Medical Image Management Software is a vendor-neutral PACS (Picture Archiving and Communication System) solution delivering enterprise-wide diagnostic images and patient reports, available for review at any time, from any location using a standard web browser.
IPACS is a single healthcare platform that allows the seamless acquisition of images from multiple types of imaging devices from a range of different equipment suppliers. It
Attachment 2 Page 1 of 4
Image /page/3/Picture/17 description: The image shows the logo for Visbion. The logo consists of the word "visbion" in lowercase letters, with a blue curved line above the word. The word "visbion" is in a light gray color. The logo is simple and modern.
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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014
is a true clinical repository with the ability to harmonise all departments within a hospital. The approach to connectivity is based on three key standards; Digital Imaging and Communications in Medicine (DICOM) 3.0, Health Level Seven International (HL7) and Integrating the Healthcare Enterprise (IHE).
Using a standard web browser registered users have the ability to log in thus provide secure access to images from diagnostic workstation in hospitals and consulting rooms plus from off-site storage facilities. 24 hours a day.
The device is constructed from the four software elements. These elements are combined according to the configuration required by the user. These terms are used by the user, IPACs being a general term to consolidate the following four elements:
Image Archive lmage Viewer Image Web Image Importer
9. Intended use and indication for use:
IPACS Medical Image Management Software is used for viewing medical images.
IPACS Medical Image Management Software receives, stores and archives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, secondary capture devices, scanners, imaging gateways or imaging sources). IPACS Medical Image Management Software can be integrated with an institutions existing Hospital Information System (HIS) or Radiology Information System (RIS) for fully integrated electronic patient records.
IPACS Medical Image Management Software can be used to retrieve, process and display medical images and patient information from any connected workstation. Users have access to various image processing and measurement tools to assist them in viewing images. In addition, users can overlay templates on medical images to aid in pre-operative planning and annotations and measurements to aid in diagnosis.
Typical users of IPACS Medical Image Management Software are trained medical professionals, including but not limited to radiologists, technologists and clinicians.
10. Technoloqical characteristics:
IPACS is a stand-alone software package comprising four components that can be installed on a number of different hardware platforms, providing that the minimum hardware specification requirements are met. The system can transmit images to remote viewing workstations over a medical imaging network. None of the software components makes contact with the patient, nor do they control any life-sustaining devices. A qualified physician will review and interpret the images and information displayed in order to make clinical decisions.
The following comparison of the technological characteristics of the IPACS Medical Image Management Software and the predicate device, eFilm Workstation with Modules, illustrates that the characteristics are the same.
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Image /page/4/Picture/14 description: The image shows the word "visbion" in a sans-serif font, with a curved line above it. The word is in lowercase letters and is a light gray color. The curved line above the word is a dark blue color. The logo is simple and modern.
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Visbion Limited IPACS Medical Image Management Software - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - - -
Comparison of Technological Characteristics:
| Ref.
No. | Technological
Characteristic | Candidate Device
IPACS Medical Image
Management Software | Predicate Device
eFilm Workstation
with Modules |
|-------------|--------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 1 | Type of Device | Software only product
residing on a PC
Workstation or server. | Software only product
residing on a PC
Workstation or server. |
| 2 | Type and Source
of Images | Digital images received
from various modalities
and digitised images via a
network or the internet. | Digital images received from
various modalities and
digitised images via a
network or the internet. |
| 3 | Scope of Image
Processing | Displays files received as
images from any third
party modality where the
third party manufacturer
has provided appropriate
DICOM drivers | Displays files received as
images from any third party
modality where the third
party manufacturer has
provided appropriate
DICOM drivers |
| 4 | Display of an
Image | On a visual display unit. A
hardcopy can be sent to a
suitable third party laser
printer. | On a visual display unit. A
hardcopy can be sent to a
suitable third party laser
printer. |
| 5 | Processing of an
Image | Permits interactive
positioning of an image.
Permits interactive sizing
of an image (length, angle,
area etc).
Permits interactive rotation
of an image.
Permits interactive
adjustment of contrast and
brightness of an image.
Not applicable. | Permits interactive
positioning of an image.
Permits interactive sizing of
an image (length, angle,
area etc).
Permits interactive rotation
of an image.
Permits interactive
adjustment of contrast and
brightness of an image.
Permits mechanical linking
of components associated
with prosthetic templates
and trauma templates
(fixation device) - via third
party accessories - see
below.
Permits integration of third
party accessories such as
orthopaedic templating and
trauma processing.
Permits interactive display
or three dimensional
images.
Permits interactive
rendering on an image.
Supports Hanging
Protocols. |
| Ref.
No. | Feature | Candidate Device
IPACS Medical Image
Management Software | Predicate Device
eFilm Workstation
with Modules |
| 6 | Means of
Collecting Data | From pre-obtained digital
images. | From pre-obtained digital
images. |
| 7 | Processing of
Data | The software processes
data and provides an
indication of the extent of
quality loss. Images are
stored lossless. | The software processes
data and provides an
indication of the extent of
quality loss. Images are
stored lossless. |
| 8 | Standards
Compliance | Digital Imaging and
Communications in
Medicine (DICOM) 3.0
Joint
Photographic
Experts
Group (JPEG)
Standard
Health Level Seven
International (HL7)
Integrating the Healthcare
Enterprise (IHE) | Digital Imaging and
Communications in
Medicine (DICOM) 3.0
Joint Photographic Experts
Group (JPEG) Standard
Health Level Seven
International (HL7)
Integrating the Healthcare
Enterprise (IHE) |
| 9 | Stand-alone
Software | Yes | Yes |
| 10 | Can be used on
Multiple Hardware
Platforms | Yes - provided that stated
minimum hardware
requirements are met. | Yes - provided that stated
minimum hardware
requirements are met. |
| 11 | Transmit Images
to Remote
Viewing Stations
Over an Imaging
Network | Yes | Yes |
Image /page/5/Picture/4 description: The image shows the logo for Visbion. The logo consists of the word "visbion" in lowercase, sans-serif font, with a curved line above the word. The word and the curved line are in a light gray color. The curved line is slightly thicker in the middle and tapers off towards the ends.
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Visbion Limited IPACS Medical Image Management Software 510(k) K140797 Response to Al e-mail December 3, 2014
From the above information it is concluded that the IPACS Medical Image Management Software is substantially equivalent to the eFilm Workstation with Modules predicate device.
This concludes the 510(k) Summary.
Image /page/6/Picture/4 description: The image shows the logo for Visbion. The logo consists of the word "visbion" in lowercase letters, with a blue curved line above the word. The word "visbion" is in a light gray color. The logo is simple and modern.