Visaris Avanse

• K Number: K150725
• Device Name: Visaris Avanse
• Manufacturer: VISARIS d.o.o. Belgrade
• Date Cleared: 2015-06-08 ( 80 days)
• Product Code: KPR LLZ
• Regulation Number: 892.1680

Intended Use

The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.

Device Description

Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.

Predicate Devices

K091364

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard digital radiography imaging and PACS software with image processing features, but there is no mention of AI or ML technology.

Therapeutic

No.
The device is described as diagnostic imaging software for acquiring, storing, processing, and displaying medical X-ray images, primarily used by medical professionals for diagnostic purposes rather than direct therapeutic intervention.

Diagnostic

Yes

Explanation: The "Intended Use / Indications for Use" states that the device's purpose is to "acquire, store, communicate, display and process medical X-ray images" and that it offers features "routinely used by medical professionals, such as radiologists and radiographers." The "Device Description" further clarifies that it provides "functionality for digital radiography examinations" and can include "diagnostic workstation software." The "Summary of Performance Studies" mentions that images acquired were "evaluated by a board certified radiologist and were found to be of excellent diagnostic quality," implying their use in diagnosis. These elements collectively indicate that the device is intended for use in the diagnostic process.

SaMD (Software as a Medical Device)

Yes

The device description explicitly states "Visaris Avanse ® is autonomous software and involves no hardware."

IVD (In Vitro Diagnostic)

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

Here's why:

• IVDs are used to examine specimens derived from the human body. The description of Visaris Avanse® clearly states its purpose is to acquire, store, communicate, display, and process medical X-ray images. X-ray imaging is a non-invasive technique that does not involve the examination of bodily specimens.
• The intended use and device description focus on image management and processing. The functionalities described (acquiring, storing, displaying, processing X-ray images, DICOM communication, worklist management) are typical of medical imaging software and PACS systems, not IVDs.
• There is no mention of analyzing biological samples or providing diagnostic information based on such analysis. The diagnostic quality mentioned in the performance studies refers to the quality of the X-ray images for interpretation by a radiologist, not the results of an in vitro test.

Therefore, Visaris Avanse® falls under the category of medical imaging software, not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

National Medical Products Administration (NMPA)

Intended Use / Indications for Use

The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.
Not intended for mammography.

Product codes (comma separated list FDA assigned to the subject device)

KPR, LLZ

Device Description

Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.

Mentions image processing

Yes

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

X-ray

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

medical professionals, such as radiologists and radiographers

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 testing:
The complete Visaris Avanse® PACS system configuration has been assessed and tested at the factory and has passed all in-house criteria. The Verification and Validation plan was design to evaluate all input and output functions, and actions performed by Visaris Avanse® PACS software in each operation mode and followed the process documented in the Validation Test Plan. Validation testing indicate that as required by risk analysis, designated individuals performed all verification and validation activities and that the result demonstrated that the predetermine acceptance criteria were met. If the device is installed by Visaris, installation and integration verification tests are conduct against acceptance criteria prior to release to client.
Clinical testing:
Clinical images were obtained using each of the declared compatible digital panels. The images were evaluated by a board certified radiologist and were found to be of excellent diagnostic quality.

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.

K091364

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

§ 892.1680 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.

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 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

June 8, 2015

VISARIS d.o.o. Belgrade % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Court NAPLES FL 34114

Re: K150725

Trade/Device Name: Visaris Avanse® Regulation Number: 21 CFR 892.1680 Regulation Name: Stationary x-ray system Regulatory Class: II Product Code: KPR, LLZ Dated: May 12, 2015 Received: May 14, 2015

Dear Mr. Kamm:

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.

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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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours,

Robert A Ochs

Robert Ochs. Ph.D. Acting 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) K150725

Device Name Visaris Avanse®

Indications for Use (Describe)

The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse supports printing to DICOM compatible printers. Within a network environment Visaris Avanse may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse has a modular system architecture. It consists of the basic application, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse also provides a user interface for generator control and image acquisition of medical images DR detectors.

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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1. Administrative Information

Reason for Submission:

510(k) Notification for Visaris Avanse®, a new device

Submitter:

| Address: | VISARIS d.o.o. Belgrade
Batajnički drum 10 deo 1b
11080 Zemun
SERBIA |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submission contact person:
Contact telephone:
Contact e-mail:
Date prepared:
Common device name:
Classification:
Regulation #s.:
Product codes: | Mr. Milan Ratković
[phone]
[e-mail]
May 12, 2015
Stationary X-Ray System (accessory)
Class II
21 CFR 892.1680 and 21 CFR 892.2050
KPR and LLZ |
| Substantially equivalent device: | |
| Device Name(s): | dicomPACS® 5.2 - dicomPACS DX-R® 1.6 |
| Manufacturer: | Oehm & Rehbein GmbH |
| Product Code: | LLZ |
| Regulation Number: | 21 CFR 892.2050 |
| Common Product Name: | Radiological Image Processing System |
| 510(k) Number: | K091364 |

2. Device description: 21 CFR 807 92 (a) (4)

Visaris Avanse® is a digital radiography imaging, control and management software (for imaging consoles) that works with DR flat panel detectors technology. Visaris Avanse® PACS provides functionality for digital radiography examinations from patient search and entry, generator control, image acquisition and processing to DICOM data archiving and export. Visaris Avanse® PACS can also include a number of Digital Radiology modules such as network DICOM archive (PACS module). DICOM modality worklist module and diagnostic workstation software to turn it into digital radiology department on a PC for small clinics. Visaris Avanse ® is autonomous software and involves no hardware. It runs under the MS Windows XP/7/8 operating system on any hardware platform meeting the minimum system requirements.

3. Indications for Use: 21 CFR 807 92 (a) (5)

The purpose of Visaris Avanse® is to acquire, store, communicate, display and process medical X-ray images. It offers features (e.g. window leveling, zoom, measurements, annotations etc.) routinely used by medical professionals, such as radiologists and radiographers. Visaris Avanse® supports printing to DICOM compatible printers. Within a network environment Visaris Avanse® may provide other modalities with a DICOM worklist and a DICOM worklist service. Images and worklists can be sent and received using the DICOM protocol. Visaris Avanse® has a modular

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system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. Beside the basic functionality Visaris Avanse® also provides a user interface for generator control and image acquisition of medical images DR detectors. Not intended for mammography.

4. Technological characteristics: 21 CFR 807 92 (a) (6)

Visaris Avanse/PACS ® has a modular system architecture. It consists of the basic application for image acquisition, processing and viewing as well as a number of other modules for image and worklist management, archiving, search and display. The software has been validated for compatibility with digital panels previously cleared by FDA and has been validated for control compatibility with the following list of generators:

Manufacturer	Product Name
Sedecal, Spain	All models
Claymount, Switzerland	Clayrad Series
Spellman, Germany	HFe Series
EMD, Canada	All models
CPI, Canada	Indico100, CMP

The image formats used are: DICOM, TIFF, BMP, PNG, JPEG, RAW (new)

Image Compression:

Visaris Avanse/PACS use the following compression methods within the DICOM standard:

• JPEG Baseline (Process 1): Lossy JPEG 8 Bit Image Compression .
• JPEG Extended (Process 2 & 4): Lossy JPEG 12 Bit Image Compression (Process 4 . only)
• JPEG Extended (Process 3 & 5) ●
• JPEG Spectral Selection. Non-Hierarchical (Process 6 & 8) ●
• JPEG Lossless, Non-Hierarchical (Process 14) ●
• JPEG Lossless, Non-Hierarchical, First-Order Prediction (Process 14 [Selection Value . 11)
• JPEG-LS Lossless Image Compression
• JPEG-LS Lossy (Near-Lossless) Image Compression ●
• JPEG 2000 Image Compression (Lossless Only)
• JPEG 2000 Image Compression ●

These compression methods are defined in the DICOM standard. Support of them is optional.

The modules are:

• 1. Avanse® DR image acquisition module
• 2. X-ray Generator Control Module
• 3. Minet Server internal communication module
• 4. CDViewer module
• 5. RIS Interface module
• 6. Avanse® DR service shell module
• 7. VisarisPACS database module
• 8. Worklist Server module
• 9. Dics Burn server module

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10. Worklist generator module

• 11. Diagon DICOM image viewer module
      The interfaces are:
• 1. DR flat panel
• 2. X-ray generator
• 3. HTTP
• 4. DICOM Store (SCP)
• 5. DICOM Send (SCU)
• 6. DCIOM Print (SCU)
• 7. Worklist Query (SCP)

5. Non clinical testing

The complete Visaris Avanse® PACS system configuration has been assessed and tested at the factory and has passed all in-house criteria. The Verification and Validation plan was design to evaluate all input and output functions, and actions performed by Visaris Avanse® PACS software in each operation mode and followed the process documented in the Validation Test Plan. Validation testing indicate that as required by risk analysis, designated individuals performed all verification and validation activities and that the result demonstrated that the predetermine acceptance criteria were met. If the device is installed by Visaris, installation and integration verification tests are conduct against acceptance criteria prior to release to client.

6. Clinical testing

Clinical images were obtained using each of the declared compatible digital panels. The images were evaluated by a board certified radiologist and were found to be of excellent diagnostic quality.

7. Substantial Equivalence Discussion

The Visaris Avanse® has the same essential indications for use as the predicate and uses the same kind of platform (Windows PC) to perform its functions. The same kind of software validation and panel testing has been performed. It is DICOM compatible like the predicate and handles jpeq images like the predicate.

| dicomPACS®5.2 and dicomPACS DX-R
K091364, Oehm und Rehbein GmbH
(Predicate Device) | VISARIS AVANSE®
(New Device)
[Equivalence Level] | Equivalence Justification |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Design | | |
| Overall software architecture:
A front-end + back-end architecture.
Front-end includes user interface realised
through „stand-alone" user applications.
Back-end includes image and metadata
databases and background services that
operate on them. Front and back end are
linked through DICOM standard protocol
communication. DICOM communication
realised trough service provider-client
model, back end provides the service and
front end is its client. | Overall software architecture:
A front-end + back-end architecture.
Front-end includes user interface realised
through „stand-alone" user applications.
Back-end includes image and metadata
databases and background services that
operate on them. Front and back end are
linked through DICOM standard protocol
communication. DICOM communication
realised trough service provider-client
model, back end provides the service and
front end is its client.
[EQUIVALENT] | None required. They are
EQUIVALENT. |
| dicomPACS®5.2 and dicomPACS DX-R
K091364, Oehm und Rehbein GmbH | VISARIS AVANSE®
(New Device) | Equivalence Justification |
| (Predicate Device)
Software architecture back end:
Integrated database of image, examination
and patient data linking acquired image files
on the file system (local or network storage).
Windows services (background processes
with no user interface) handle data transfer
to and from database and ensure database
integrity. | [Equivalence Level]
Software architecture back end
Integrated database of image, examination
and patient data linking acquired image files
on the file system (local or network storage).
Windows services (background processes
with no user interface) handle data transfer
to and from database and ensure database
integrity.
[EQUIVALENT] | None required.
They are
EQUIVALENT. |
| Software architecture front end:
Front end is realised throught several static
windows (win32) applications implementing
main user interface functionality including
image acquisition, exam scheduling and
image review.
Only one application entity active on the
user interface at any time.
Win32 applications implement
DICOM
communication clients to communicate
with services in the back-end and external
DICOM services. | Software architecture front end:
Front end is realised throught several static
windows (win32) applications implementing
main user interface functionality including
image acquisition, exam scheduling and
image review.
Only one application entity active on the
user interface at any time.
Win32 applications implement DICOM
communication clients to communicate
with services in the back-end and external
DICOM services.
Exam scheduling user interface is also
realised through web based interface.
[PRACTICALLY EQUIVALENT] | Web interface architecture
is used to collect user input,
but not process it. Main
processing functionality is
still performed in the back
end and the web interface
is implemented on a win32
process within a browser. |
| Communication to external components:
Realised through each
component's
proprietary communication protocol using
standard interface/data exchange protocols
(such as RS232 or TCP-IP). Connections to
components managed locally on the main
system PC through component proprietary
software (SDK) interfaces implemented in
dynamicly linked libratries (dlls).
Communication from main system software
realised through direct calls to exposed
functions of the SDK contained within the
dlls. Data transfer realised through common
memory access. | Communication to external components:
Realised through each
component's
proprietary communication protocol using
standard interface/data exchange protocols
(such as RS232 or TCP-IP). Connections to
components managed locally on the main
system PC through component proprietary
software (SDK) interfaces implemented in
dynamicly linked libratries (dlls).
Communication from main system software
realised through direct calls to exposed
functions of the SDK contained within the
dlls. Data transfer realised through common
memory access.
[EQUIVALENT] | None required.
They are
EQUIVALENT. |
| dicomPACS®5.2 and dicomPACS DX-R
K091364, Oehm und Rehbein GmbH
(Predicate Device) | VISARIS AVANSE®
(New Device)
[Equivalence Level] | Equivalence Justification |
| User Interface design
Multiple application enetites with related
but separate user interface to cover
different workflow aspects (DR/CR
acquisition and patient entry, database
search, image viewing, examination
scheduling).
User interface is graphical with clear display
of acquired or retreived images and system
information on the screen as well as data
entry fields.
Action commands are input by the user as
mouse clicks on command buttons, menus,
results lists and data entry fields.
Textual data input is handled through
keyboard/touchscreen keyboard input. | User Interface design
Multiple application enetites with related
but separate user interface to cover
different workflow aspects (DR/CR
acquisition and patient entry, database
search, image viewing, examination
scheduling).
User interface is graphical with clear display
of acquired or retreived images and system
information on the screen as well as data
entry fields.
Action commands are input by the user as
mouse clicks on command buttons, menus,
results lists and data entry fields.
Textual data input is handled through
keyboard/touchscreen keyboard input.
[EQUIVALENT] | None required. They are
EQUIVALENT. |
| Development Platform:
Main development platform Microsoft
Windows development platform (.NET
Technologies: ADO.NET Entity Framework,
LINQ, ADO.NET, XML, ODATA Protocol,
Native: ODBC, ADO, MSDASQL, Database:
SQL Serever Database Engine, SQL Server
Integration Services SSIS, SQL Server
Reporting Services SSRS). | Development Platform:
Main development platform Microsoft
Windows development platform (.NET
Technologies: ADO.NET Entity Framework,
LINQ, ADO.NET, XML, ODATA Protocol,
Native: ODBC, ADO, MSDASQL, Database:
SQL Serever Database Engine, SQL Server
Integration Services SSIS, SQL Server
Reporting Services SSRS). Android mobile
platform used for UI extension to mobile
devices.
[PRACTICALLY EQUIVALENT] | Main development platform
is equivalent. Android
platform is additionally used
on Visaris Avanse only to
collect user actions from
mobile devices. System
actions are not processed
on this platform, rather on
the same main platform as
predicate device.
Functionality verified. |
| PC Platform | PC Platform | |
| Common Personal Computer (PC) platform,
static or mobile (laptop, tablet). | Common Personal Computer (PC) platform,
static or mobile (laptop, tablet).
[EQUIVALENT] | None required. They are
EQUIVALENT. |
| Material | Material | |
| Software only product, no material
included. | Software only product, no material
included.
[EQUIVALENT] | None required. They are
EQUIVALENT. |
| Chemical Composition | Chemical Composition | |
| Software only product, no chemical
composition. | Software only product, no chemical
composition.
[EQUIVALENT] | None required. They are
EQUIVALENT. |
| Energy Source | Energy Source | |
| Software only product, no energy source
included. | Software only product, no energy source
included.
[EQUIVALENT] | None required. They are
EQUIVALENT. |

Substantial Equivalence Table

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8. Substantial Equivalence Conclusion: After analyzing software validation, risk analysis, and clinical images, it is the conclusion of VISARIS d.o.o. Belgrade Inc that the VISARIS AVANSE® is as safe and effective as the predicate device, have few technological differences, and has the same indications for use, thus rendering it substantially equivalent to the predicate device.