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 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 measurements (for example 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.

Device Description

Agfa's ICIS® View system 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.

The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a web-browser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes.

The optional Full Fidelity functionality allows the retrieval of original lossless renditions of stored CR, DX, CT, MR, and US images for diagnostic purposes on select mobile devices or FDA cleared display monitors when there is no access to a full workstation.

AI/ML Overview

The provided text describes the 510(k) submission for AGFA Healthcare's ICIS® View device. This device is a Picture Archiving and Communications System (PACS) software intended for reference viewing of medical images and associated reports. The submission aims to demonstrate substantial equivalence to previously marketed predicate devices.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly present a formal "acceptance criteria table" with specific quantitative metrics (e.g., sensitivity, specificity, or numerical performance thresholds for image quality). Instead, the acceptance is based on demonstrating substantial equivalence to predicate devices, primarily through qualitative evaluations of image quality and functional parity.

The core acceptance criterion is that the ICIS® View system performs equivalently to the predicate devices in terms of diagnostic image quality when used in "Full Fidelity" mode.

Acceptance Criterion (Implicitly from substantial equivalence)	Reported Device Performance
Diagnostic Image Quality equivalent to predicate PACS workstation (IMPAX 6.6.1) for CR, DX, CT, MR, US modalities on both desktop and mobile (iPad® 3, iPad® 4).	Qualified radiologists evaluated a sample set of images across 3 platforms: ICIS® View Desktop (with FDA cleared diagnostic monitor), ICIS® View Mobile (with calibrated iPad® 3 and iPad® 4), and Agfa's full diagnostic PACS workstation IMPAX 6.6.1 (predicate). They provided an "acceptable" or "unacceptable" score when comparing diagnostic quality, including evaluations of contrast, sharpness, artifacts, and overall image quality. The overall finding was that "Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicates." This implies the performance was "acceptable" and equivalent.
Compliance with TG18 Image Quality Assessment Parameters.	The "Assessment of Display Performance for Medical Imaging Systems" (TG18-QC, TG18-BR, TG18-LP) was used for display device assessment. "All results met acceptance criteria."
Functional Equivalence/Parity with Predicate Devices.	The device demonstrates functional parity with predicate devices in terms of communication (DICOM), no mammographic use, support for CR, DX, CT, MR, US modalities, operating systems (Windows & iOS), mobile device support, transfer/storage/display of images, network access, user authentication, window/level, rotate/pan/zoom, measurements, and annotations. The differences (server vs. app-based) do not alter the intended diagnostic effect.
Product and manufacturing processes conform to relevant standards.	The product, manufacturing, and development processes conform to ACR/NEMA PS3.1-3.20: 2011 DICOM, ISO 14971:2012 (Risk Management), and ISO 13485:2003 (Quality Management Systems).
Risk assessment demonstrates acceptable residual risk.	"During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with a conventional PACS system previously released to the field. For ICIS® View there are a total of 20 risks in the broadly acceptable region and two risks in the ALARP region. Zero risks were identified in the Not Acceptable Region." The overall benefits are determined to outweigh the residual risks.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: A "sample set of an average of 6 imaging studies per modality (CR, DX, CT, MR, US)" was evaluated. This means approximately 30 studies in total (6 studies * 5 modalities).
Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. It refers to "laboratory data" and "image quality evaluations conducted with qualified radiologists," suggesting existing image datasets were used for testing, which typically points to retrospective data.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

Number of Experts: The document states "qualified radiologists" were used. The exact number of radiologists is not specified.
Qualifications of Experts: The experts are described as "qualified radiologists," indicating they are medical professionals specializing in radiology. No specific experience levels (e.g., "10 years of experience") are provided in the text.

4. Adjudication Method for the Test Set

The document states that qualified radiologists "were asked to provide an acceptable or unacceptable score when comparing the diagnostic quality...to the IMPAX predicate." This suggests a comparative evaluation rather than a direct adjudication for "ground truth" of disease presence. The adjudication here seems to be on the equivalence of display quality for diagnostic interpretation rather than agreement on specific findings. No specific multi-reader adjudication method (e.g., 2+1, 3+1) is described for establishing a definitive "ground truth" diagnosis for each case within the test set itself, as the assessment was comparative to a predicate display rather than a diagnostic accuracy study measuring against a reference standard.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

The study described is a comparative evaluation between the new device and a predicate device by "qualified radiologists." While radiologists evaluated multiple cases, the study's primary goal was to establish display equivalence for diagnostic purposes, rather than a formal MRMC study aimed at quantifying the effect size of AI assistance on human reader performance.
Effect Size of AI vs. Without AI Assistance: This study did not involve AI assistance. The ICIS® View device is a PACS viewer, not an AI diagnostic tool. Therefore, an MRMC comparative effectiveness study regarding AI assistance was not applicable and not conducted. The comparison was between two different display systems (ICIS® View vs. IMPAX Workstation).

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done

As ICIS® View is a PACS viewer software, not a diagnostic algorithm, the concept of "standalone performance" in the context of an algorithm's diagnostic accuracy is not directly applicable.
The performance evaluation focused on the visual equivalence of the images displayed by the device compared to a predicate, as interpreted by human radiologists. It is a human-in-the-loop assessment of the display quality.

7. The Type of Ground Truth Used

The "ground truth" in this context is not a pathological diagnosis or clinical outcome, but rather the "diagnostic quality" provided by the predicate system (Agfa's IMPAX 6.6.1 workstation). Radiologists were asked to assess whether the ICIS® View's display quality was "acceptable" when compared to the established diagnostic quality of the predicate. This is a form of expert consensus/comparison against an established standard (the predicate's display) for the purpose of demonstrating substantial equivalence of image rendering.

8. The Sample Size for the Training Set

The document does not mention a "training set" for the ICIS® View device, as it is a PACS viewing software, not a machine learning or AI model that requires a data-driven training phase. The development and testing focused on software functionality and image display fidelity.

9. How the Ground Truth for the Training Set was Established

Since there is no mention of a training set or an AI/ML component, this question is not applicable based on the provided text.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines connecting them.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

June 1, 2015

AGFA Healthcare N.V. % Ms. Shaeann Cavanagh Regulatory Affairs Specialist NA AGFA Healthcare 10 South Academy Street GREENVILLE SC 29601

Re: K143397

Trade/Device Name: ICIS View Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: April 24, 2015 Received: April 27, 2015

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 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 (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

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) K143397

Device Name

ICIS® View

Indications for Use (Describe)

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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510(K) SUMMARY Agfa HealthCare's ICIS® View

Common Name: Picture Archiving and Communications System (PACS) Classification Name: Radiological Image Processing System Regulatory Classification: 21 CFR 892.2050 Product Code: LLZ Proprietary Name: ICIS® View Agfa HealthCare N.V. Septestraat 27 B-2640 Mortsel Belgium Contact: Jodi Coleman, Prepared: November 26, 2014 Telephone: 519-746-6210 ext. 2485

LEGALLY MARKETED PREDICATE DEVICES A.

This is a 510(k) for Agfa's ICIS® View software, a picture archiving and communications It is substantially equivalent to systems with MIM Software Inc.'s Mobile MIM svstem. (K103785-primary predicate), Agfa HealthCare's IMPAX Workstation (K022292), and Client Outlook Inc.'s eUnity™ (K11164).

DEVICE DESCRIPTION B.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices. Laboratory data including, performance assessments and image quality evaluations conducted with qualified radiologists confirm that performance is equivalent to the predicates.

C. INTENDED USE

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

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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.

Intended use has not changed as a result of any labeling modification(s).

D. SUBSTANTIAL EQUIVALENCE SUMMARY

Agfa's ICIS® View system has an Indications For Use statement similar to the predicate devices (K103785, K022292, & K111164). The statements have been combined and simplified. There are no changes to the intended use/indications of the device. Intended uses are the same. The devices have the same technological characteristics.

Both ICIS® View and the primary predicate device, Mobile MIM (K103785) are used to display medical images for diagnostic purposes of multiple modalities inlcuding MR and CT. Both provide wireless and portable access to medical images on select Apple products. Furthermore, ICIS® View and Mobile MIM (K103785) 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. ICIS® View and eUnity™ (K111164) are indicated to allow image manipulations and display lossy/lossless images. Both ICIS® View and predicate device, IMPAX Workstation (K02292) are indicated to display, review, transfer, store, and archive medical images. ICIS® View and all three predicate devices (K103785, K022292, & K111164) are not indicated for mammography and all the devices accept standard DICOM transfers.

The only difference of the new device and the primary predicate device, Mobile MIM (K103785), is the new device is server based software that connects to an existing PACS; whereas, Mobile MIM contains an App that connects to the existing PACS. However, the other two predicates, IMPAX Workstation (K022292) and eUnity™ (K111164) are also server based software that connects to the existing PACS. Differences in devices do not alter the intended diagnostic effect.

The devices have the same technological characteristics. The new device and the predicate devices (K103785, K022292, & K11164) are picture archiving and communication systems (PACS), Product Code LLZ. Agfa's ICIS® View system is substantially equivalent to the predicate devices (K103785, K022292, & K111164) in that it uses precisely the same technology to capture and display medical data. Descriptive characteristics and performance data are adequate to ensure equivalence.

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Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence.

predicate devices.
	ICIS® View(New Device)	Mobile MIM(PrimaryPREDICATE-K103785)	IMPAXWorkstation(PREDICATE-K022292)	eUnity™(PREDICATE-K111164)
Communication	Same as predicates	DICOM	DICOM	HL7, DICOM, IHE
Mammographic Use	Same as predicates	No	No	No
Modalities forDiagnostic Use	CR, DX, CT, MR, US	SPECT, PET,CT, MR	Radiology(including CR, DX,CT, MR, US)	Radiology(including CR, DX, CT,MR, US)
Operating System forDiagnostic Viewing	Windows 7 & iOS8	iOS	Windows 7 & 8	Windows & iOS
Mobile DeviceSupport forDiagnostic Viewing	iPad® 3, iPad® 4	Apple iOShandheld devices
Transfer/Storage/Display of Medical Images	Same as predicates	Yes	Yes	Yes
Network Access	Same as K022292 &K111164	App thatconnects toexisting PACS	Server basedsoftware, connects toexisting PACS	Server based software,connects to existingPACS
User Authentification	Same as predicates	Yes	Yes	Yes
Window Level	Same as predicates	Yes	Yes	Yes
Rotate/Pan/Zoom	Same as predicates	Yes	Yes	Yes
Measurements	Same as predicates	Yes	Yes	Yes
Annotations	Same as predicates	Yes	Yes	Yes
Indications for UseStatements	ICIS® View is a softwareapplication used forreference viewing ofmedical images andassociated reports and, assuch, fulfills a key role inAgfa HealthCare's ImagingClinical Information System(ICIS). ICIS® View enableshealthcare professionals,including (but not limitedto) physicians, surgeons,nurses, and administrators toreceive and view patientimages and data frommultiple departments and	The MobileMIM softwareprogram is usedfor theregistration,fusion, and/ordisplay fordiagnosis ofmedical imagesfrom only thefollowingmodalities:SPECT, PET,CT, and MRI.	IMPAX Workstationswith MPR, DigitalSubtraction and 3Doptions are intendedfor use in theacquisition, display,digital processing,review, transfer,storage, archivingand printing ofmedical images andpatient demographicinformation.	eUnity™ is a softwareapplication that displaysmedical image data andassociated clinical reports.eUnity™ performsoperations relating to thetransfer, storage, displayand measurement ofimage data.eUnity™ allows users toperform imagemanipulations, includingwindow/level, rotation,
Indications for UseStatements continued..	organizations within onemulti-disciplinary viewer.Users may access theproduct directly via a web-browser, select mobiledevices, healthcare portal orwithin the ElectronicMedical Record (EMR).ICIS® View allows users toperform basic imagemanipulations andmeasurements (for examplewindow/level, rotation,zoom, and markups).ICIS® View can optionallybe configured for FullFidelity mode, which isintended for diagnostic use,review and analysis of CR,DX, CT, MR, US imagesand medical reports. ICIS®View Full Fidelity is notintended to replace fulldiagnostic workstations andshould only be used whenthere is no access to aworkstation.ICIS® View full fidelity isnot intended for the displayof digital mammographyimages for diagnosis.	Mobile MIMprovides wirelessand portableaccess to medicalimages. Thisdevice is notintended toreplace fullworkstations andshould be usedonly when thereis no access to aworkstation.The device is notto be used formammography.	They are indicatedfor use by thephysician to aid indiagnosis, and bymedical professionalswhenever they wouldrequire or desireaccess to medicalimages and patientdemographicinformation.MPR and 3Dfunctions allow theuser to view 3Dimage data fromperspectives differentfrom that in which itwas acquired. Digitalsubtraction allows auser viewing timeseries studies toremove densities notenhanced by acontrast medium,highlighting vascularstructures.	zoom, measurement andmarkup.eUnity™ displays bothlossless and lossycompressed images. Forlossy images, the medicalprofessional user mustdetermine if the level ofloss is acceptable for theirpurposes.Display monitors used forreading medical imagesfor diagnostic purposesmust comply withapplicable regulatoryapprovals and withquality controlrequirements for their useand maintenance.Mammographic imagesand digitized film screenimages must not bereviewed for primaryimage interpretations..

Table 1 on the below summarizes the similarities and differences between the new device and predicate devices.

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Table 1: Device Predicate Comparison

TECHNOLOGICAL CHARACTERISTICS E.

It is a software device running on commercially available computer equipment that allows users to view and modify DICOM compliant medical images and patient information.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices. The new device is substantially equivalent to the predicate devices (K103785, K022292, & K111164). It is a multidisciplinary viewer that allows the user to securely access patient images and reports from any PACS or vendor-neutral archive. Images and reports can be viewed directly via a webbrowser, select mobile device, healthcare portal or Electronic Medical Record (EMR). The new

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device includes some of the clinical tools of the predicate devices specifically the functionality to retrieve original lossless renditions of stored images for diagnostic purposes. There are no differences between the device and the predicates (K103785, K022292, & K111164) that impact safety and effectiveness.

F. TESTING

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).

No animal or clinical studies were performed in the development of the new device. No patient treatment was provided or withheld.

ICIS® View vs. Agfa IMPAX (K02292) - Requirements & Performance of the full fidelity view were evaluated:

To determine substantial equivalence, diagnostic image quality was evaluated by qualified medical professionals comparing images across 3 platforms:

ICIS® View Desktop - using an FDA clearaed diagnostic monitor
ICIS® View Mobile using a calibrated iPad® 3 and iPad® 4 ●
Agfa's full diagnostic PACS workstation IMPAX 6.6.1 (K022292 predicate) ●

A sample set of an average of 6 imaging studies per modality (CR, DX, CT, MR, US) were evaluated. Qualified radiologists were asked to provide an acceptable or unacceptable score when comparing the diagnostic quality, including evaluations of contrast, sharpness, artifacts and overall image quality in ICIS® View Full Fidelity mode (both desktop and mobile) to the IMPAX predicate.

2. Display Device Assessment - TG18 Testing

The executed validation plan for image quality required calibrated display devices for all assessments.

A direct comparison of all images discussed was conducted such that envrionmental conditions, the evaluator, infrastructure etc. were all identical to make the best comparison assessment possible.

To assess and compare the overall image quality of the display devices used for validation the "Assessment of Display Performance for Medical Imaging Systems" was used (TG18-QC, TG18-BR, TG18-LP).

All results met acceptance criteria.

Performance data including resolution testing and image quality evaluations by qualified radiologists are adequate to ensure equivalence to the predicates.

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The product, manufacturing and development processes conform to product safety and medical imaging standards including:

PRODUCT STANDARD G.

. ACR/NEMA PS3.1-3.20: 2011 Digital Imaging and Communications in Medicine (DICOM).

OUALITY MANAGEMENT STANDARDS

ISO 14971:2012 Application of Risk Management to Medical Devices
ISO 13485:2003 Medical Devices Quality Management Systems Requirements For ● Regulatory purposes

RISK ASSESSMENT AND MANAGEMENT SUMMARY H.

During the final risk analysis meeting, the risk management team concluded that the medical risk is no greater than with a conventional PACS system previously released to the field.

For ICIS® View there are a total of 20 risks in the broadly acceptable region and two risks in the ALARP region. Zero risks were identified in the Not Acceptable Region. Therefore, the device is assumed to be safe, the benefits of the device are assumed to outweigh the residual risk.

The benefits of ICIS® View are:

Image and information review capabilities are enhanced over what is offered by traditional film: ●
- Immediate access to all available prior patient studies. о
- Time independent access to patient records and information. o
- Simultaneous access to multimodality, multi-departmental image review (a chest x-ray, o an, MRI, and CT for example).
Improved resource utilization of both equipment and staff. ●
- Improved communication between local and geographically separated healthcare o providers promoting collaborative care.
- Authorized Users are able to share same patient record and contribute to that record. O
Distribution of clinical data either through digital access, distribution or hardcopy print. .

The residual risk of each hazardous situation was analyzed and it was determined that the overall benefits to the patient outweigh the residual risks.

CONCLUSIONS I.

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Both ICIS® View and the primary predicate device. Mobile MIM (K103785) are used to display medical images for diagnostic purposes of multiple modalities inlcuding MR and CT. Both provide wireless and portable access to medical images on select Apple products. Furthermore, ICIS® View and Mobile MIM (K103785) 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. ICIS® View and eUnity™ (K111164) are indicated to allow image manipulations and display lossy/lossless images. Both ICIS® View and predicate device, IMPAX Workstation (K02292) are indicated to display, review, transfer, store, and archive medical images. ICIS® View and all three predicate devices (K103785, K022292, & K111164) are not indicated for mammography and all the devices accept standard DICOM transfers.

Principles of operation and technological characteristics of the new and predicate devices are the same. There is no change to the intended use of the device vs. the predicate devices.

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.

Regulation Number and Section

§ 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).