Examion X-AQS

K170729 · Examion GmbH · LLZ · Jul 18, 2017 · Radiology

Device Facts

• Record ID: K170729
• Device Name: Examion X-AQS
• Applicant: Examion GmbH
• Product Code: LLZ · Radiology
• Decision Date: Jul 18, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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.

Device Story

Enterprise PACS software for digital X-ray image acquisition, processing, and management. Inputs: DICOM image data from digital X-ray detectors and other modalities (CT, MRT, US). Operation: Interfaces with X-ray detectors and generators to configure exposure parameters (kVp, mA, mAs); performs image enhancement (window/level, rotation, zoom, measurement, stitching); manages study data; supports DICOM 3.x, HL7, and JPEG standards. Output: Processed diagnostic images for review, storage, or printing. Used in clinical settings by trained professionals. Enhances workflow via integration with hospital networks and RIS workstations. Benefits: Facilitates efficient image handling, storage, and diagnostic review; supports standardized communication across clinical environments.

Clinical Evidence

Bench testing only. No clinical data provided. System performance verified against pre-determined functional requirements and software specifications; hazard analysis classified as moderate level of concern.

Technological Characteristics

Software-based PACS; DICOM 3.x, HL7, and JPEG compliant. Operates on standard network hardware (10/100/1000 Ethernet). Minimum display resolution 1024x768. Interfaces with digital X-ray detectors and generators via manufacturer-provided algorithms. Supports image manipulation (window/level, rotation, stitching, measurement).

Indications for Use

Indicated for trained professionals (physicians, radiologists, nurses, technicians) to acquire, process, store, manage, and review digital X-ray images. Contraindicated for creation of fluoroscopic, radioscopic, or angiographic images.

Regulatory Classification

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.

Special Controls

*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).

Predicate Devices

• ARIX RAD ACQUISITION CONSOLE (K123650)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. Inside the circle is a stylized image of a human figure, with three faces in profile, representing the department's mission to protect the health of all Americans.

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.

{1}------------------------------------------------

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [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.

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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K170729

Device Name Examion X-AQSTM

#### Indications for Use (Describe)

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.

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. | | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| This section applies only to requirements of the Paperwork Reduction Act of 1995. | | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* | | |
| The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff<br>PRAStaff(@fda.hhs.gov | | |
| "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of | | |

information unless it displays a currently valid OMB number."

{3}------------------------------------------------

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: [phone] Fax: [phone] Email: [e-mail]

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 RADIOLOGIA<br>CGR, 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,

{4}------------------------------------------------

# 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)

{5}------------------------------------------------

- 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 if<br>Any |
|----------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------|
| Intended Use | Software, used together<br>with a digital X-ray<br>detector is a digital X-ray<br>image processing system<br>designed for acquiring<br>images and processing<br>acquired images. The<br>main features of the<br>software are controlling<br>and interfacing the<br>detector, acquiring images<br>after X-ray, storing<br>acquired images,<br>managing data, optimizing<br>window level and width of<br>acquired images, rotating<br>images, zooming images,<br>measuring images and<br>other features used for<br>imaging processing. | Software, used together<br>with a digital X-ray<br>detector is a digital X-ray<br>image processing system<br>designed for acquiring<br>images and processing<br>acquired images. The<br>main features of the<br>software are controlling<br>and interfacing the<br>detector, acquiring images<br>after X-ray, storing<br>acquired images,<br>managing data, optimizing<br>window level and width of<br>acquired images, rotating<br>images, zooming images,<br>measuring images and<br>other features used for<br>imaging processing. | Substantially the<br>same |
| Intended user | Radiologist | Radiologist | None |
| Network | 10/100/100 Ethernet | 10/100/100 Ethernet | Substantially the<br>same |
| Monitor | Above 19inch monitor<br>(Above 1280x900) | Minimum display<br>resolution 1024 X 768 | Substantially the<br>same |
| Feature/Function | Predicate Device | Subject Device | Difference if<br>Any |
| User<br>interaction/input | Mouse, keyboard, touch<br>monitor | Mouse, keyboard, touch<br>monitor | Substantially the<br>same |
| Import / export<br>images | Yes | Yes | Substantially the<br>same |
| Acquisition<br>devices | Computed radiography<br>Digital X-Ray detector | DR | Slight<br>difference.<br>Subject device<br>only<br>uses Digital X-<br>Ray<br>detectors to<br>acquire<br>images, |
| Imaging interfaces | Yes | Yes | Substantially the<br>same |
| Image<br>organization | Yes. Patient ID, Name,<br>study instance UDI | Yes | Substantially the<br>same |
| Image search<br>available | Yes | Yes | Substantially the<br>same |
| Image storage | Yes | Yes | Substantially the<br>same |
| Image viewing | Yes | Yes | Substantially the<br>same |
| Image<br>measurement | Yes | Yes | Substantially the<br>same |
| Image<br>annotation | Yes | Yes | Substantially the<br>same |
| Image<br>operations | Yes | Yes | Substantially the<br>same |
| Security | Yes | Yes | Substantially the<br>same |
| DICOM 3.0<br>compatibility | Yes | Yes | Substantially the<br>same |
| Generator Control | Yes | Yes | Substantially the<br>same |
| Generator<br>Control Protocol | Yes | Yes | Substantially the<br>same |
| RAW Image data<br>processing | Yes | Yes | Substantially the<br>same |
| Post image data<br>processing | Yes | Yes | Substantially the<br>same |
| Worklist | Yes | Yes | Substantially the<br>same |
| Patient<br>size/Laterality | Yes | Yes | Substantially the<br>same |
| Display<br>radiographic<br>technique, kV,<br>mA, ms, mAs | Yes | Yes | Substantially the<br>same |
| Thumbnail<br>viewing | Yes | Yes | Substantially the<br>same |
| Feature/Function | Predicate Device | Subject Device | Difference if<br>Any |
| Login | Yes | Yes | Substantially the same |
| New patient<br>manual register | Yes | Yes | Substantially the same |
| X-Ray generator<br>window | Yes | Yes | Substantially the same |
| Bucky selection | Yes | Yes | Substantially the same |
| Body part | Yes | Yes | Substantially the same |
| Generator status<br>display | 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 |

{6}------------------------------------------------

# 510(k) Summary of Safety and Effectiveness

{7}------------------------------------------------

# 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".