XEBRA DICOM IMAGE BROWSER

K071894 · Hx Technologies, Inc. · LLZ · Aug 16, 2007 · Radiology

Device Facts

• Record ID: K071894
• Device Name: XEBRA DICOM IMAGE BROWSER
• Applicant: Hx Technologies, Inc.
• Product Code: LLZ · Radiology
• Decision Date: Aug 16, 2007
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.2050
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

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 Story

Xebra DICOM Image Browser is a web-based software application for viewing/manipulating medical images (CT, MR, US, RF, CR, DR) acquired from various sources. Operates on standard workstations; integrates with HIS, RIS, EMR, or EHR. Users (radiologists, clinicians, technologists) perform image adjustments (window/level, stacking, annotation, measurement, inversion, rotation, flips). Device does not contact patient or control life-sustaining equipment. Provides visual output for clinical review; supports diagnostic decision-making by trained professionals. Benefits include centralized access to patient imaging records across distributed networks.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Stand-alone software package; platform-independent (requires minimum hardware). DICOM-compliant. Supports image processing and measurement. No patient contact. Software development follows internal product development process; hazard analysis classified as Minor.

Indications for Use

Indicated for viewing medical images (CT, MR, US, RF, CR, DR, secondary capture) by trained medical professionals (radiologists, clinicians, technologists). Contraindicated for primary interpretation of lossy compressed mammographic images and digitized film screen images; mammography requires FDA-approved 5 Mpixel monitors.

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

• UniPACS Workstation (K023476)
• eFilm Workstation (K012211)

Submission Summary (Full Text)

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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: [phone]

## Contact Person

David H. Kates, COO, Hx Technologies Inc Phone: [phone] x18 Email: [e-mail]

### 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<br>(K023476)<br>Universal PACS, Inc.<br>127 Albert Hart Drive<br>Baton Rouge, LA 70803<br>www.unipacs.com | eFilm Workstation<br>(K012211)<br>eFilm Medical Inc.<br>500 University Ave, Suite 300<br>Toronto, Ontario<br>Canada M5G 1V7<br>www.efilm.ca |
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|
|-------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|

## 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.

### Indications for Use

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

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.

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.

# 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.
- 2. 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 [phone] or [phone]

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:

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.

(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