(38 days)
Not Found
No
The document describes a standard DICOM image viewer with basic image manipulation functions. There is no mention of AI, ML, or any advanced analytical capabilities that would typically involve these technologies. The "digital image processing" mentioned refers to standard image adjustments like windowing and leveling, not AI-driven analysis.
No.
The device is a software application for viewing and manipulating existing medical images, not for providing therapy or controlling therapeutic devices.
Yes
The device is described as allowing users to perform tasks like "adjustment of window width and level; image stacking; annotation and measurement of regions of interest; and inversion, rotation, and flips of images" when viewing medical images. These functions are typically associated with tools used by medical professionals for diagnosis. Additionally, it specifies that "Typical users... are trained medical professionals, including but not limited to radiologists, clinicians, technologists," who use these images for medical interpretation, even though primary interpretation of some mammographic images is restricted.
Yes
The device is explicitly described as a "software application" and a "component of a Picture Archiving and Communications System (PACS)". The description focuses solely on the software's functions for viewing and manipulating medical images. There is no mention of accompanying hardware components that are part of the device itself.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device function: The Xebra DICOM Image Browser is a software application for viewing and manipulating medical images acquired from various imaging modalities (CT, MR, US, etc.). It processes and displays images, but it does not analyze biological samples from the patient.
- Intended Use: The intended use clearly states it's for "viewing medical images" and performing tasks like adjusting window levels, annotating, and measuring regions of interest on these images.
- Device Description: The description reinforces that it's a software application for image viewing and manipulation within a PACS system. It explicitly states the device "does not contact the patient, nor does it control any life sustaining devices."
The device deals with medical images, which are a form of diagnostic information, but it does not perform the diagnostic test itself on a biological sample. It's a tool for interpreting the results of imaging procedures.
N/A
Intended Use / 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.
Product codes
LLZ
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.
Mentions image processing
digital image processing and measurement capability
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
CT, MR, US, RF units, computed and direct radiographic devices, and secondary capture devices, (scanners, imaging gateways or imaging sources)
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Typical users of the Xebra Image Viewer are trained medical professionals, including but not limited to radiologists, clinicians, technologists, and others.
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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 Drive
Baton Rouge, LA 70803
www.unipacs.com | eFilm Workstation
(K012211)
eFilm Medical Inc.
500 University Ave, Suite 300
Toronto, Ontario
Canada M5G 1V7
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
1
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.
-
- The submission contains the results of a hazard analysis and the "Level of Concern for potential hazards has been classified as "Minor".
2
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
3
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
4
(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