(140 days)
No
The document describes a medical image viewer (PACS) with standard image manipulation and display features. There is no mention of AI, ML, or any related technologies in the intended use, device description, or performance studies.
No
Explanation: This device is a software application for viewing and managing medical images and data for diagnostic and reference purposes. It does not directly treat or prevent a disease or condition, which is the characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" and "Device Description" sections explicitly state the device is used for "diagnostic viewing" and "diagnostic purposes." The text also mentions "mobile diagnostic use" and that "Uncompressed 'for presentation' images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use." Additionally, the performance studies involved evaluating "diagnostic image quality."
Yes
The device is described as a "software application" and a "web based software application". While it interacts with hardware (monitors, iPads), the device itself is presented solely as software. The validation testing focuses on software performance and image quality display, not on the hardware itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Definition of IVD: In Vitro Diagnostic devices are used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- Device Description: The description clearly states that the Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application for viewing and managing medical images and associated reports. It is described as a Picture Archiving and Communication System (PACS).
- Intended Use: The intended use is for viewing and manipulating medical images and non-imaging data for reference and diagnostic purposes. This involves interpreting visual information from imaging modalities like CR, DX, CT, MR, US, and ECG.
- No mention of biological specimens: The text does not mention the analysis of any biological specimens.
Therefore, the device falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
Product codes (comma separated list FDA assigned to the subject device)
LLZ
Device Description
Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer.
It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CR, DX, CT, MR, US, ECG
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators
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)
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.
Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30).
XERO Viewer vs. Agfa Enterprise Imaging Desktops (K142316) - Requirements & Performance of Xtend (full fidelity) diagnostic desktop viewing were evaluated (note Xtend Full Fidelity is not supported on mobile devices):
To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 2 platforms:
- Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316) - using an FDA cleared diagnostic monitor
- XERO Viewer Xtend full fidelity using an FDA cleared diagnostic monitor
A sample set of an average of 5 or 6 imaging studies per modality were evaluated. Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality in XERO Viewer to the Enterprise Imaging Diagnostic Desktop. The executed validation plan for image quality was performed on calibrated diagnostic display devices.
To evaluate ECG viewing users were asked to display ECG's in DICOM and PDF formats, change layouts, adjust waveforms and use the tools provided (zoom, measurements). Validation and non-clinical (bench) testing was performed on an iPad mobile device to ensure that the views and functionality performed consistently between desktop and a mobile platform.
Performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicate.
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.
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
Public Health Service
Image /page/0/Picture/2 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 an abstract symbol resembling a stylized caduceus, with three human profiles forming the staff of the symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 3, 2017
Agfa HealthCare N.V. % ShaeAnn Cavanagh, RAC Regulatory Affairs Manager, North America Agfa HealthCare Corporation 10 South Academy Street GREENVILLE SC 29601
Re: K170434
Trade/Device Name: Enterprise Imaging XERO Viewer 8.1 Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: May 30, 2017 Received: May 31, 2017
Dear Ms. Cavanagh:
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
1
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.
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,
Robert Ochs
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) K170434
Device Name
Enterprise Imaging XERO Viewer 8.1
Indications for Use (Describe)
Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multi-disciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use, review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
| 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) |
|---|---|
| --------------------------------------------------------------------------------------------------------------------------------------------- | -------------------------------------------------------------------------------------------------------------------------------------------- |
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3
510(K) SUMMARY:
Agfa HealthCare's Enterprise Imaging XERO Viewer
I. SUBMITTER
Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jodi Coleman, Prepared: February 10, 2017 Telephone: 519-746-6210 ext 2485
II. DEVICE
Name of Device: Enterprise Imaging XERO Viewer 8.1 Common Name: System, Image Processing, Radiological Classification Name: Picture Archiving and Communications System (PACS) Regulatory Classification: Class II, 21 CFR 892.2050 Product Code: LLZ
III. PREDICATE DEVICES
This is a 510(k) for Agfa's Enterprise Imaging, which is a picture archiving and communications system. It is substantially equivalent to Carestream Health's Vue Motion (K151774) and Agfa HealthCare's ICIS View (K143397).
These predicate devices have not been subject to a design-related recall.
IV. DEVICE DESCRIPTION
Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer.
It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.
4
The only difference of the new device and the primary predicate device, Carestream Vue Motion (K151774) is the new device does not support mobile diagnostic viewing on other handheld devices other than an iPad. Differences in devices do not alter the intended diagnostic effect.
Principles of operation and technological characteristics of the new and predicate devices are the same.
INTENDED USE
Agfa HealthCare's Enterprise Imaging XERO Viewer 8.1 is a software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents and, as such, fulfills a key role in the Enterprise Imaging solution. XERO Viewer 8.1 enables healthcare professionals, including (but not limited to) physicians, surgeons, nurses, and administrators to receive and view patient images, documents and data from multiple departments and organizations within one multidisciplinary viewer. XERO Viewer 8.1 allows users to perform image manipulations (including window/level, markups, 3D visualization) and measurements.
When images are reviewed and used as an element of diagnosis, it is the responsibility of the trained physician to determine if the image quality is suitable for their clinical application. Lossy compressed mammography images and digitized film images should not be used for primary image interpretation. Uncompressed or non-lossy compressed "for presentation" images may be used for diagnosis or screening on monitors that are FDA-cleared for their intended use.
XERO Viewer 8.1 can optionally be configured for Full Fidelity Mobile, which is intended for mobile diagnostic use. review and analysis of CR, DX, CT, MR, US, ECG images and medical reports. XERO Viewer Full Fidelity Mobile is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer Full Fidelity Mobile is not intended for the display of mammography images for diagnosis.
Intended use has not changed as a result of any labeling modification(s).
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH V. PREDICATE DEVICES
Agfa's Enterprise Imaging XERO Viewer has an Indications For Use statement similar to predicate devices (K151774, K143397)). The statements have been combined and simplified. The devices have the same technological characteristics.
5
Both XERO Viewer and the primary predicate device, Carestream Vue Motion (K151774) are used to display medical images for diagnostic purposes of multiple modalities. Both provide wireless and portable access to medical images on select validated mobile devices. Furthermore, XERO Viewer Full Fidelity and Vue Motion contain a statement that it is not intended to replace full diagnostic workstations and should only be used when there is no access to a workstation. XERO Viewer and Vue Motion (K151774) are indicated to allow image manipulations, 3D viewing capabilities and display lossylossless images. Both XERO Viewer and Vue Motion (K151774) require the use of FDA approved display hardware for primary interpretation and review of mammography images.
Enterprise Imaging XERO Viewer is a web based software application used for reference and diagnostic viewing of multi-specialty medical imaging and non-imaging data with associated reports and documents. It is a picture archiving and communication system (PACS), product code LLZ, intended to provide an interface for the display, annotation, review, printing, storage and distribution of multimodality medical images, reports and demographic information for review and diagnostic purposes within the system and across computer networks. XERO Viewer enables authenticated users to search for and display patient studies (reports and images) using a web browser, user's do not need to download or install any additional software or plug-ins to use XERO Viewer.
It is the successor to Agfa's ICIS View predicate (K143397) and adds the following new functionality: it adds Xtended study viewing) desktop diagnostic support for additional modalities, supports Xtend 3D visualization and ECG mobile (Full Fidelity) diagnostic support utilizing the newer iPad version.
The only difference of the new device and the primary predicate device, Carestream Vue Motion (K151774) is the new device does not support mobile diagnostic viewing on other handheld devices other than an iPad. Differences in devices do not alter the intended diagnostic effect.
The devices have the same technological characteristics. The new device and the predicate devices (K151774, K143397) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's XERO Viewer system is substantially equivalent to the predicate devices (K151774, K143397) in that it uses precisely the same technology to capture and display medical data.
Descriptive characteristics and performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence. Differences in devices do not alter the intended therapeutic/diagnostic effect.
Table 1 on the next page summarizes the similarities and differences between the new device and predicates.
6
| | Enterprise Imaging
XERO Viewer
NEW DEVICE | Carestream Vue
Motion
(K151774)
PRIMARY
PREDICATE | Agfa HealthCare's
ICIS View
(K143397) |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Communication | Same as predicates | DICOM | DICOM |
| Modalities | Including CR, DX, CT, MR, US, ECG | Including CR, DR, CT,
MR, NM, US, ECG | CR, DX, CT, MR, US |
| Modalities Full Fidelity
Mobile Diagnostic | CR, DX, CT, MR, US, ECG | Including CR, DR, CT,
MR, NM, US, ECG | CR, DX, CT, MR, US |
| Mammography Use | Same as primary predicate | Yes | No |
| Mobile Device Support
for Diagnostic Viewing | iPads | iPads, iPhones,
Galaxy Note, Galaxy S | iPads |
| Transfer/Storage/Display
of Medical Images | Same as predicates | Yes | Yes |
| Network Access | Web browser connects to existing
PACS | Web browser connects
to existing PACS | Web browser connects to
existing PACS |
| User Authentication | Same as primary predicate | Yes | Yes |
| Window Level | Same as primary predicate | Yes | Yes |
| Rotate/Pan/Zoom | Same as primary predicate | Yes | Yes |
| Measurement | Same as primary predicate | Yes | Yes |
| Annotation | Same as primary predicate | Yes | Yes |
| 3D Visualization | Same as primary predicate | Yes | No |
| Indications for Use | Software application used for reference
and diagnostic viewing of
multispecialty medical imaging and
non-imaging data with associated
reports and documents and, as such,
fulfills a key role in the Enterprise | Program is used for
patient management by
clinicians in order to
access and display
patient data, medical
reports, medical data, | ICIS® View is a software
application used for reference
viewing of medical images and
associated reports and, as such,
fulfills a key role in Agfa
HealthCare's Imaging Clinical |
| | Imaging solution.
Enables healthcare professionals,
including (but not limited to)
physicians, surgeons, nurses, and
administrators to receive and view
patient images,
documents and data from multiple
departments and organizations within
one multidisciplinary viewer.
Viewer allows users to perform image
manipulations (including window/level,
markups, 3D visualization) and
measurements.
When images are reviewed and used as
an element of diagnosis, it is the
responsibility of the trained physician
to determine if the image quality is
suitable for their clinical application. | and medical images for
diagnosis from different modalities including
CR, DR, CT, MR, NM,
ECG,
and US.
Provides wireless and
portable access to
medical
images for remote
reading
or referral purposes
from web browsers
including usage with
validated mobile
devices.
Not intended to
replace full | Information System (ICIS).
ICIS® View enables healthcare
professionals, including (but
not limited to) physicians,
surgeons, nurses, and
administrators to receive and
view patient images and data
from multiple departments and
organizations within one multi-
disciplinary viewer.
Users may access the product
directly via a web-browser,
select mobile devices,
healthcare portal or within the
Electronic Medical Record
(EMR). ICIS® View allows
users to perform basic image
manipulations and |
| Enterprise Imaging
XERO Viewer
NEW DEVICE | Carestream Vue
Motion
(K151774)
PRIMARY
PREDICATE | Agfa HealthCare's
ICIS View
(K143397) | |
| images and digitized film images
should not be used for primary image
interpretation. Uncompressed or non-
lossy compressed "for presentation"
images may be used for diagnosis or
screening on monitors that are FDA
cleared for their intended use.
Can optionally be configured for Full
Fidelity Mobile, which is intended for
mobile diagnostic use, review and
analysis of CR, DX, CT, MR, US, ECG
images and medical reports.
Full Fidelity Mobile is not
intended to replace full
diagnostic workstations and
should only be used when there is no
access to a workstation.
Full Fidelity Mobile is not intended for
the display of mammography images
for diagnosis. | and should be used only
when there is no access
to a
workstation. For
primary
interpretation and
review of
mammography images,
only
use display hardware
that is
specifically designed
for and
cleared by FDA for
mammography. | window/level, rotation, zoom.,
and markups).
ICIS® View can optionally be
configured for Full Fidelity
mode, which is intended for
diagnostic use, review and
analysis of CR, DX, CT, MR,
US images and medical reports.
ICIS® View Full Fidelity is not
intended to replace full
diagnostic workstations and
should only be used when there
is no access to a workstation.
ICIS® View full fidelity is not
intended for the display of
digital mammography images
for diagnosis. | |
7
Table 1: Device Comparison Table
PERFORMANCE DATA VI.
Verification and validation testing confirmed the device meets performance, safety, usability and security requirements. No clinical trials were performed in the development of the device.
There are no applicable FDA mandated performance standards for this device. However, Agfa's in-house standard operating procedures were used for the development of the software; these procedures conform to the following standards:
- ISO 13485:2003 Medical Devices Quality Management Systems ●
- ISO 14971:2012 Application of Risk Management to Medical Devices ●
- ISO 27001:2013 Information Security Management ●
- ISO 62366:2007 Medical Devices Application of usability engineering to medical ● devices
- IEC 62304:2006 Medical Device Software - Software life cycle processes
- ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine ● (DICOM)
Laboratory testing and software testing (for a moderate level of concern device) using equivalent test protocols as used for Medical Image Management Devices as part of verification and validation under design controls (according to 21 CFR 820.30).
8
No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.
XERO Viewer vs. Agfa Enterprise Imaging Desktops (K142316) - Requirements & Performance of Xtend (full fidelity) diagnostic desktop viewing were evaluated (note Xtend Full Fidelity is not supported on mobile devices):
To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 2 platforms:
- . Enterprise Imaging 8.0.0 Diagnostic Desktop (K142316) - using an FDA cleared diagnostic monitor
- XERO Viewer Xtend full fidelity using an FDA cleared diagnostic monitor ●
A sample set of an average of 5 or 6 imaging studies per modality were evaluated. Qualified radiologists were asked to provide an overall score when comparing the diagnostic image quality in XERO Viewer to the Enterprise Imaging Diagnostic Desktop. The executed validation plan for image quality was performed on calibrated diagnostic display devices.
To evaluate ECG viewing users were asked to display ECG's in DICOM and PDF formats, change layouts, adjust waveforms and use the tools provided (zoom, measurements). Validation and non-clinical (bench) testing was performed on an iPad mobile device to ensure that the views and functionality performed consistently between desktop and a mobile platform.
Performance data including image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicate.
Summarv
Based on the performance data as documented in the above testing, XERO Viewer is found to have a safety and effectiveness profile that is similar to the predicate device.
VII. CONCLUSIONS
The device has indications for use that are consistent with those of the legally marketed predicate device. Where technological characteristics differ lab tests concluded that the device is substantially equivalent to the predicate in that it does not alter the intended therapeutic/diagnostic effect.
This 510(k) 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.