Xebra DICOM Image Browser ™ is a software application that is used for viewing medical images. The Xebra Image Viewer receives digital images and data from various sources (including but not limited to CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources). Images are stored, communicated, processed and displayed on the local disk of a workstation and/or across computer networks at distributed locations. Tasks that users may perform when viewing images include, but are not limited to: adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images. In addition, the Xebra Image Viewer can be integrated with an institution's existing HIS, RIS, EMR, or EHR for a fully integrated electronic patient record. Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretation. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 Mpixel resolution and meets other technical specifications reviewed and accepted by FDA.

Device Description

Xebra DICOM Image Browser ™ is one of the components of a Picture Archiving and Communications System (PACS). Xebra DICOM Image Browser ™ is a software application that provides image viewing and manipulation in a web browser. The functions of this application are applied to medical images that are acquired and stored on an image server in DICOM and or other proprietary formats. The device does not contact the patient, nor does it control any life sustaining devices.

AI/ML Overview

This submission (K071894) is for the Xebra DICOM Image Browser, which is a Picture Archiving and Communications System (PACS) software. The document does not contain a specific study proving the device meets detailed acceptance criteria in the manner typically expected for diagnostic or AI-powered devices.

Instead, this 510(k) summary focuses on demonstrating substantial equivalence to predicate devices (UniPACS Workstation K023476 and eFilm Workstation K012211) for the purpose of image viewing and manipulation. The "acceptance criteria" here are more about the software's functionality and safety as a medical device, rather than a performance benchmark against a specific medical condition.

Here's an analysis based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

The document does not provide a table of quantitative acceptance criteria for image viewing performance (e.g., accuracy, sensitivity, specificity, or image quality metrics) or specific reported device performance values. The device is a PACS image browser, and its "performance" is primarily assessed by its ability to perform standard image viewing, manipulation, and integration functions.

The acceptance criteria are implicitly met by:

Conforming to the functional capabilities of predicate devices: The device is stated to be "substantially equivalent" to UniPACS Workstation and eFilm Workstation, implying it performs the same functions.
Meeting software development and testing standards: "Xebra DICOM Image Browser ™ has been tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of Hx Technologies' software development process as described in the company's Product Development Process."
Adherence to voluntary standards: The device "has been and will continue to be manufactured according to the voluntary standards list in the Voluntary Standards section of the submission." (The specific standards are not listed in this excerpt).
Hazard Analysis: A hazard analysis classified the "Level of Concern for potential hazards" as "Minor."

Reported Device Performance: The document does not report specific quantitative metrics of the device's performance (e.g., image clarity, speed of rendering, accuracy of measurements). Its performance is described in terms of its features and capabilities:

Viewing medical images from various sources (CT, MR, US, RF units, etc.).
Storing, communicating, processing, and displaying images.
User tasks: adjustment of window/level, image stacking, annotation, measurement, inversion, rotation, flips.
Integration with HIS, RIS, EMR, EHR.

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

The document does not specify a sample size for any test set or provide details on data provenance (e.g., country of origin, retrospective/prospective). The testing mentioned is related to software verification and validation, not clinical performance evaluation with a specific patient dataset.

3. Number of Experts Used to Establish Ground Truth and Qualifications:

This information is not provided. As the device is a PACS viewer and not an AI/CAD system, the concept of "ground truth" for a test set in the diagnostic performance sense is not directly applicable to the information presented. The functionality testing would involve internal quality assurance and verification against software specifications.

4. Adjudication Method for the Test Set:

This information is not provided.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A MRMC comparative effectiveness study was not mentioned or performed for this device. The submission does not describe any human reader performance studies, with or without AI assistance, or related effect sizes.

6. Standalone (Algorithm Only) Performance Study:

A standalone performance study, as typically understood for diagnostic algorithms, was not mentioned or performed. The device itself is a standalone software application, but its "performance" is on its capabilities as a viewer, not a diagnostic algorithm.

7. Type of Ground Truth Used:

Ground truth, in the context of clinical accuracy (e.g., for disease detection), is not relevant to the information provided in this 510(k) summary. The "ground truth" for this device would be its adherence to DICOM standards, correct rendering of images, and accurate execution of viewing and manipulation functions. This would typically be verified through software testing against design specifications, not clinical pathology or outcomes data.

8. Sample Size for the Training Set:

This information is not applicable and not provided. The Xebra DICOM Image Browser is a conventional image viewer software, not an AI or machine learning algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable and not provided, as there is no training set for this type of device.

Summary

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K07/894

510(k) Summary of Safety and Effectiveness

Date Prepared

May 27, 2007

Submitter's Information

Hx Technologies Inc 340 North 12th St, #321 Philadelphia, PA 19107 Phone: (215) 923-4984

Contact Person

David H. Kates, COO, Hx Technologies Inc Phone: (215) 923-4984 x18 Email: david.kates@hxti.com

Device

Trade Name:	Xebra DICOM Image Browser ™
Common Name:	Picture Archiving and Communications System
Classification Name:	PACS (per 21 CFR 892.2050), LLZ, Class II

Substantially Equivalent to both:

UniPACS Workstation(K023476)Universal PACS, Inc.127 Albert Hart DriveBaton Rouge, LA 70803www.unipacs.com	eFilm Workstation(K012211)eFilm Medical Inc.500 University Ave, Suite 300Toronto, OntarioCanada M5G 1V7www.efilm.ca
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Device Description

Indications for Use

AUG 1 6 2007

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510(k) Summary of Safety and Effectiveness

of images. In addition, the Xebra Image Viewer can be integrated with an institution's existing HIS, RIS, EMR, or EHR for a fully integrated electronic patient record. Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.

Technological Characteristics

The Xebra DICOM Image Browser ™ is a stand-alone software package which can be used on more than one hardware platform, as long as minimum hardware requirements are met and allows digital image processing and measurement capability. The Xebra Image Viewer 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/or printed.

Testing

Xebra DICOM Image Browser ™ has been tested according to the specifications that are documented in a Software Test Plan. Testing is an integral part of Hx Technologies' software development process as described in the company's Product Development Process.

Conclusion

The 510(k) pre-market notification for the Xebra DICOM Image Browser ™ contains adequate information and data to enable FDA-CDRH to determine substantial equivalence to the predicate device.

The Xebra Image Viewer has been and will continue to be manufactured 1. according to the voluntary standards list in the Voluntary Standards section of the submission.
1. The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor".

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Image /page/2/Picture/0 description: The image shows a circular logo for the U.S. Department of Health & Human Services. The logo features the department's symbol, which consists of three stylized lines resembling a human figure. The text "U.S. Department of Health & Human Services" is arranged around the circle's perimeter.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 16 2007

Hx Technologies, Inc. % Mr. Carl Alletto Consultant OTECH, Inc. 1600 Manchester Way CORINTH TX 76210

Re: K071894

Trade/Device Name: Xebra DICOM Image Browser™ Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: LLZ Dated: July 4, 2007 Received: July 17, 2007

Dear Ms. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such 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.

Image /page/2/Picture/10 description: The image shows a circular logo with the text "1906-2006" at the top. The letters "FDA" are prominently displayed in the center, with the word "Centennial" underneath. Three stars are arranged below the word "Centennial". The text "Protecting and Promoting Your Health" is written around the bottom of the circle.

conoling Public Hoath

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Page 2 -

Please be advised that FDA's issuance of a substantial equivalence determination does not mean i hat FDA has made a determination that your device complies with other requirements of the Act that I Dr Hes mass and regulations administered by other Federal agencies. You must or any I violal satisfrequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set Cl K Pat 607), laooinig (21 CD) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) This letter unfrance yourse FDA finding of substantial equivalence of your device to a legally prematicated predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:

21 CFR 876.xxx	(Gastroenterology/Renal/Urology)	240-276-0115
21 CFR 884.xxx	(Obstetrics/Gynecology)	240-276-0115
21 CFR 894.xxx	(Radiology)	240-276-0120
Other		240-276-0100

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under (21 Cr 1 C r at 60 : 0 : 17 ] . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . toll-free number (800) 638-2041 or (240) 276-3150

on at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C. Hogdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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(Indications for Use Form)

510(k) Number:

Device Name:

Xebra DICOM Image Browser TM

Indications for Use:

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

D. Whang

(Division Sign-Off) Division of Reproductive, Abdomin Radiological Devices 510(k) Number

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).