The Examion X-AQS™ software, used together with a digital X-ray detector is a digital X-ray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, measuring images and other features used for imaging processing. The Examion X-AQS™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.x by using DICOM and network systems. Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians. Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/ radioscopic. or angiographic images. The main functions of the Examion X-AQS™ system are: a) Acquisition and storage of digital X-ray images from a digital X-ray Detector, b) Input Study information (natient information, exam information), c) Management of stored (archived) images, d) Image processing for enhancement of archived images, e) Review of stored images, f) Editing of images, g) DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.), h) For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) or a need to interface with installed X-ray system, the . Ability to configure X-ray exposure condition (kVp, mA, Sec etc.) for various body parts and positions. · Communication between Generator Console and Examion X-AQS™. The X-ray generator control function depends on the X-ray Generator company. The X-ray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the X-ray Company. The Examion X-AQS™ system can only select or change values of X-ray exposure parameters (kVp. mA second or kVp. mAs) according to the defined value determined by each X-rav company. The Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ software cannot be interfaced with X-ray Generator.

Device Description

The EXAMION X-AQS system is an enterprise Picture Archiving and Communications System (PACS) used to handle DICOM digital medical images and other associated data. The system enables the receipt of DICOM images from various imaging devices (modalities) like CT, MRT, US DICOM and enables their storage, retrieval, distribution, image manipulation and examination for diagnostic purposes, annotation and report generation The EXAMION X-AQS software system is customizable and scalable to meet various enterprise functional and size requirements. It is a standard based system Integrating the Health Enterprise (IHE) profiles. Digital Imaging and Communications in Medicine (DICOM). Joint Photographic Expert Group (JPEG) and Health Level Seven (HL-7) protocol standards for managing digital medical images as well as patient data. The EXAMION X-AQS supports all types of diagnostic radiographic images, mammography, endoscopy and multi-frame studies. The EXAMION X-AQS console comprise of two major components: - . EXAMION X-AQS PACS Server: A server receives image data in DICOM format from archives, modalities and workstations via universal connections via the hospital network. EXAMION X-AQS PACS Server provides archiving for short term and long term archive. The system provider has to take own appropriate means like redundancy for safety against data loss. - . EXAMION X-AQS PACS Viewer: Client server system that is used to view, edit, manipulate, annotate, and analyze imaqe that are stored on EXAMION X-AQS PACS server. All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the image. These changes are saved as a display definition (Presentation states) only and do not alter the acquired image pixel data. All display definitions can be reversed to the original state at any time System interfaces The EXAMION X-AQS software acts in two different ways based on the application. Firstly, as EXAMION X-AQS PACS system involves the interaction between various input devices like RIS work station, diagnostic station (or monitors) or Twain scanner documentation, US grabber, Digitizer CR and DR or any DICOM device and output device. Secondly as a standalone acquisition station which receives images from 3rd party RIS work station and sends to 3rd party PACS systems. The following block diagrams showing the major components of the larger system and interconnections that may be helpful to understand the Examion X-AQS in detail

AI/ML Overview

This document is a 510(k) Premarket Notification for the Examion X-AQS™ system, a Picture Archiving and Communications System (PACS) software. The purpose of this submission is to demonstrate substantial equivalence to a legally marketed predicate device, not to provide evidence of a new clinical claim or an AI algorithm's performance in diagnostic tasks.

Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria in the context of an AI/ML algorithm's diagnostic performance.

Specifically:

A table of acceptance criteria and the reported device performance: This document does not present a table of quantitative performance metrics for a diagnostic task or an AI algorithm. Its acceptance criteria are based on functional equivalence to a predicate PACS system and compliance with standards.
Sample sizes used for the test set and the data provenance: Not applicable, as no diagnostic performance study for an AI/ML algorithm is described. The document mentions "testing" of the complete system configuration at the factory, but this refers to functional testing, not a clinical performance evaluation on a test set of medical images.
Number of experts used to establish the ground truth... and their qualifications: Not applicable.
Adjudication method for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done...: Not applicable.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: Not applicable.
The type of ground truth used: Not applicable.
The sample size for the training set: Not applicable.
How the ground truth for the training set was established: Not applicable.

What the document does provide:

Device Description: The Examion X-AQS™ is a PACS software system used for acquiring, storing, retrieving, processing, manipulating, and displaying digital medical images (DICOM). It interfaces with various imaging devices (like digital X-ray detectors) and other hospital systems (RIS).
Intended Use: The software, together with a digital X-ray detector, is a digital X-ray image processing system. It enables image acquisition, storage, management, processing (e.g., window/level, rotation, zooming, measurement), and review. It's compatible with DICOM 3.x.
Users: Trained professionals, e.g., physicians, radiologists, nurses, and medical technicians.
Predicate Device: ARIX RAD ACQUISITION CONSOLE (K123650).
Demonstration of Substantial Equivalence: The submission primarily focuses on showing that the Examion X-AQS™ has substantially equivalent technological characteristics and intended use to its predicate device. This is done through a comparison table (pages 5-6) highlighting features and functions. The key difference noted is that the subject device "only uses Digital X-Ray detectors to acquire images" compared to the predicate's use of Computed Radiography and Digital X-ray detectors.
Testing: The document states, "The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures." This refers to functional and performance testing of the software system, not a clinical study to prove diagnostic accuracy of an AI component.
Conclusion: The submission contains "adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device." The "Level of Concern for potential hazards has been classified as 'Moderate'."

In summary, this submission is for a PACS system, not a diagnostic AI algorithm. Therefore, the detailed performance metrics and study designs typically required for AI/ML-driven diagnostic devices are not present in this document.

Summary

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

July 18, 2017

Examion GmbH % Mr. Carl Alletto Consultant OTech Inc. 8317 Belew Drive MCKINNEY TX 75071

Re: K170729

Trade/Device Name: Examion X-AQS™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: June 5, 2017 Received: June 9, 2017

Dear Mr. Alletto:

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.

Michael D. O'Hara
For

Robert Ochs. Ph. D. 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) K170729

Device Name Examion X-AQSTM

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

CONTINUE ON A SEPARATE PAGE IF NEEDED.
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information unless it displays a currently valid OMB number."

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This 510(k) Summary of Safety and Effectiveness information is being submitted in accordance with the requirements of SMDA 1990.

Date Prepared:

June 5, 2017

Submitter's Information: 21 CFR 807.92(a)(1)

Mr. Andreas Oppermann Chief Executive Officer (CEO) Examion GmbH Erich-Herion Strassa 37 70736 Fellbach, Germany Phone: +49-711-12-0002-263 Fax: +49-711-12-0002-22 Email: oppermann@examion.com

Trade Name, Common Name and Classification: 21 CFR 807.92(a)(2)

Trade Name:	EXAMION X-AQS™
Common Name:	Picture Archiving Communications System
Device Classification:	892.2050 System, Image Processing
Product Code:	LLZ

Predicate Device: 21 CFR 807. 92(a)(3)

Device Classification Name	system, image processing, radiological
510(k) Number	K123650
Device Name	ARIX RAD ACQUISITION CONSOLE
Applicant	COMPANIA MEXICANA DE RADIOLOGIACGR, S.A. DE C.V.
Regulation Number	892.2050
Classification Product Code	LLZ
Date Received	11/27/2012
Decision Date	02/20/2013
Decision	substantially equivalent (SE)
Regulation Medical Specialty	Radiology
510k Review Panel	Radiology
summary	summary
Type	Traditional

Device Description: 21 CFR 807 92(a)(4)

The EXAMION X-AQS system is an enterprise Picture Archiving and Communications System (PACS) used to handle DICOM digital medical images and other associated data.

The system enables the receipt of DICOM images from various imaging devices (modalities) like CT, MRT, US DICOM and enables their storage, retrieval, distribution,

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510(k) Summary of Safety and Effectiveness

image manipulation and examination for diagnostic purposes, annotation and report generation The EXAMION X-AQS software system is customizable and scalable to meet various enterprise functional and size requirements. It is a standard based system Integrating the Health Enterprise (IHE) profiles. Digital Imaging and Communications in Medicine (DICOM). Joint Photographic Expert Group (JPEG) and Health Level Seven (HL-7) protocol standards for managing digital medical images as well as patient data. The EXAMION X-AQS supports all types of diagnostic radiographic images, mammography, endoscopy and multi-frame studies. The EXAMION X-AQS console comprise of two major components:

. EXAMION X-AQS PACS Server: A server receives image data in DICOM format from archives, modalities and workstations via universal connections via the hospital network. EXAMION X-AQS PACS Server provides archiving for short term and long term archive. The system provider has to take own appropriate means like redundancy for safety against data loss.
. EXAMION X-AQS PACS Viewer: Client server system that is used to view, edit, manipulate, annotate, and analyze imaqe that are stored on EXAMION X-AQS PACS server.

All acquired image data is preserved in the format in which it is received. Changes may be made to the presentation of the image. These changes are saved as a display definition (Presentation states) only and do not alter the acquired image pixel data. All display definitions can be reversed to the original state at any time System interfaces The EXAMION X-AQS software acts in two different ways based on the application. Firstly, as EXAMION X-AQS PACS system involves the interaction between various input devices like RIS work station, diagnostic station (or monitors) or Twain scanner documentation, US grabber, Digitizer CR and DR or any DICOM device and output device. Secondly as a standalone acquisition station which receives images from 3rd party RIS work station and sends to 3rd party PACS systems. The following block diagrams showing the major components of the larger system and interconnections that may be helpful to understand the Examion X-AQS in detail

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

The Examion X-AQS™ software, used together with a digital X-rav detector is a digital Xray image processing system designed for acquiring images and processing acquired images. The main features of the software are controlling and interfacing the detector, acquiring images after X-ray, storing acquired images, managing data, optimizing window level and width of acquired images, rotating images, zooming images, measuring images and other features used for imaging processing. The Examion X-AQS™ system is compatible with the DICOM 3.x communications standard. It can transfer images processed in PACS and print images with a film printer compatible with DICOM 3.x by using DICOM and network systems.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using a monitor that meets technical specification identified by FDA. Typical users of this system are trained professionals, e.g. physicians, radiologists, nurses, and medical technicians.

Contraindications: Examion X-AQS™ is not intended for creation of fluoroscopic/ radioscopic, or angiographic images.

The main functions of the Examion X-AQS™ system are:

a) Acquisition and storage of digital X-ray images from a digital X-ray Detector.
b) Input Study information (patient information, exam information).
Management of stored (archived) images. c)

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d) Image processing for enhancement of archived images.
e) Review of stored images.
f) Editing of images.
DICOM conformance (e.g. DICOM Storage, DICOM Work list, DICOM Print, etc.) g)
For a DR system (X-ray machine and generator and Digital X-ray detector, etc.) h) or a need to interface with installed X-ray system, the:
- Ability to configure X-ray exposure condition (kVp, mA, Sec etc.) for various . body parts and positions.
- Communication between Generator Console and Examion X-AQS™. .

The X-ray generator control function depends on the X-ray Generator company. The Xray generator is not part of the Examion X-AQS™ system since the Examion X-AQS™ system can only interface and control the Generator by the algorithm provided by the Xray Company. The Examion X-AQS™ system can only select or change values of X-ray exposure parameters (kVp, mA second or kVp mAs) according to the defined value determined by each X-ray company.

The Examion X-AQS™ system does not control exposure and electrical charge and calibration X-ray. If the X-ray generator does not allow interfacing with external software the Examion X-AQS™ software cannot be interfaced with X-ray Generator.

Technological Characteristics: 21 CFR 807 92(a)(6)

EXAMION X-AQS™ device is a software product that acquires, handles, displays and manages digital medical images. The device does not contact the patient, nor does it control any life sustaining devices. A physician, providing ample opportunity for competent human intervention interprets images and information being displayed and printed. The general features and functions of the device are:

Feature/Function	Predicate Device	Subject Device	Difference ifAny
Intended Use	Software, used togetherwith a digital X-raydetector is a digital X-rayimage processing systemdesigned for acquiringimages and processingacquired images. Themain features of thesoftware are controllingand interfacing thedetector, acquiring imagesafter X-ray, storingacquired images,managing data, optimizingwindow level and width ofacquired images, rotatingimages, zooming images,measuring images andother features used forimaging processing.	Software, used togetherwith a digital X-raydetector is a digital X-rayimage processing systemdesigned for acquiringimages and processingacquired images. Themain features of thesoftware are controllingand interfacing thedetector, acquiring imagesafter X-ray, storingacquired images,managing data, optimizingwindow level and width ofacquired images, rotatingimages, zooming images,measuring images andother features used forimaging processing.	Substantially thesame
Intended user	Radiologist	Radiologist	None
Network	10/100/100 Ethernet	10/100/100 Ethernet	Substantially thesame
Monitor	Above 19inch monitor(Above 1280x900)	Minimum displayresolution 1024 X 768	Substantially thesame
Feature/Function	Predicate Device	Subject Device	Difference ifAny
Userinteraction/input	Mouse, keyboard, touchmonitor	Mouse, keyboard, touchmonitor	Substantially thesame
Import / exportimages	Yes	Yes	Substantially thesame
Acquisitiondevices	Computed radiographyDigital X-Ray detector	DR	Slightdifference.Subject deviceonlyuses Digital X-Raydetectors toacquireimages,
Imaging interfaces	Yes	Yes	Substantially thesame
Imageorganization	Yes. Patient ID, Name,study instance UDI	Yes	Substantially thesame
Image searchavailable	Yes	Yes	Substantially thesame
Image storage	Yes	Yes	Substantially thesame
Image viewing	Yes	Yes	Substantially thesame
Imagemeasurement	Yes	Yes	Substantially thesame
Imageannotation	Yes	Yes	Substantially thesame
Imageoperations	Yes	Yes	Substantially thesame
Security	Yes	Yes	Substantially thesame
DICOM 3.0compatibility	Yes	Yes	Substantially thesame
Generator Control	Yes	Yes	Substantially thesame
GeneratorControl Protocol	Yes	Yes	Substantially thesame
RAW Image dataprocessing	Yes	Yes	Substantially thesame
Post image dataprocessing	Yes	Yes	Substantially thesame
Worklist	Yes	Yes	Substantially thesame
Patientsize/Laterality	Yes	Yes	Substantially thesame
Displayradiographictechnique, kV,mA, ms, mAs	Yes	Yes	Substantially thesame
Thumbnailviewing	Yes	Yes	Substantially thesame
Feature/Function	Predicate Device	Subject Device	Difference ifAny
Login	Yes	Yes	Substantially the same
New patientmanual register	Yes	Yes	Substantially the same
X-Ray generatorwindow	Yes	Yes	Substantially the same
Bucky selection	Yes	Yes	Substantially the same
Body part	Yes	Yes	Substantially the same
Generator statusdisplay	Yes	Yes	Substantially the same
Image reset	Yes	Yes	Substantially the same
panning	Yes	Yes	Substantially the same
Magnify glass	Yes	Yes	Substantially the same
Fit image	Yes	Yes	Substantially the same
Stitching	Yes	Yes	Substantially the same
Series/Image list	Yes	Yes	Substantially the same

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510(k) Summary of Safety and Effectiveness

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510(k) Summary of Safety and Effectiveness

Testing

The complete system configuration has been tested at the factory and the device has passed all in-house pre-determined testing criteria without significant failures. The data presented in the submission demonstrates that EXAMION X-AQS™ performs all required actions according to the functional requirements specified in the Software Requirements Specification and the User Manual with no errors that had an impact on safety or efficacy.

Conclusion: 21 CFR 807 92(b)(1)

The 510 (k) Pre-Market Notification for EXAMION X-AQS™ contains adequate information and data to enable FDA - CDRH to determine substantial equivalence to the predicate device. EXAMION X-AQS™ has been and will be manufactured in accordance with the voluntary standards listed in the enclosed voluntary standard survey. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Moderate".

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).