(50 days)
Not Found
No
The document describes a standard medical image and information management system (PACS) with core functionalities like receiving, transmitting, storing, retrieving, displaying, and printing images. It explicitly states it will only perform "normal image manipulations for grayscale and image contrast" and "will not perform image processing on mammographic images." There is no mention of AI, ML, or any advanced image analysis or processing that would typically involve these technologies.
No
The device is described as a medical image and information management system, which primarily handles the display, storage, and processing of medical images. It does not exert a direct physical or biological effect on a patient, which is characteristic of a therapeutic device.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device "is also indicated for use in soft-copy diagnostic interpretation of medical images and video by physicians trained in such practice."
No
The device description explicitly states that the software is installed and run on commercially available IBM PC compatible computers, hardware components, and peripherals, forming a system that includes workstations, servers, and components for communication and printing. This indicates the device is a system comprised of both software and hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device's intended use: The intended use of Horizon Medical Imaging is to manage and display digital medical images and video from various medical imaging systems. It deals with images generated by modalities like X-ray, CT, MRI, etc., which are produced outside the body.
- No mention of biological specimens: The description and intended use do not mention the handling or analysis of any biological specimens.
Therefore, Horizon Medical Imaging falls under the category of medical imaging and information management systems, not In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Horizon Medical Imaging is a medical image and information management system that is intended to receive, transmit, store, retrieve, display, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images).
Horizon Medical Imaging is intended to connect to a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for primary image interpretations. Mammographic images may only be interpreted using an FDA approved monitor that offers at least 5 megapixel resolution and meets other technical specifications reviewed and approved by FDA. Horizon Medical Imaging will simply perform normal image manipulations for grayscale and image contrast on mammographic images and will not perform image processing on mammographic images.
Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft-copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft-copy diagnostic interpretation of mammographic images).
Product codes
90 LLZ
Device Description
Horizon Medical Imaging is software which when installed and run on Microsoft Windows 2000 and XP operating systems on commercially available IBM PC compatible computers, hardware components and peripherals, forms a medical image and information management system that receives, transmits, stores, retrieves, displays, prints and processes digital medical images, digital medical receives, transmits, stored, routers, alippy, a promotion medical imaging systems.
Its core components are:
- High resolution color and grayscale workstations for primary diagnostic interpretation and . secondary review of the medical images, video and related information.
- Standard workstations for performing administrative functions of the system .
- Otandard worked in the corporation for short-term and long-term storage of system . data
- Servers for managing the distribution of system data .
- Oct For handing the components for providing the communication channels between the t system's core components and the various medical imaging systems
- system o our ochiponent for producing hardcopy of medical images and related information. .
Mentions image processing
Horizon Medical Imaging will simply perform normal image manipulations for grayscale and image contrast on mammographic images and will not perform image processing on mammographic images.
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
All DICOM 3.0 recognized modalities (specifically including mammographic images).
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained medical professionals including, but not limited to, radiologists, physicians, and medical technologists.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
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
Summary of Safety and Effectiveness for Horizon Medical Imaging
Demographic Information 5.1
Date Prepared 5.1.1
October 8, 2004
Submitter 5.1.2
McKesson Medical Imaging Company 130 - 10711 Cambie Road Richmond, B.C. Canada, V6X 3G5 Tel: 604-279-5422 Fax: 604-279-5468
5.1.3 Contact
Robert MacNeil P.Eng. Manager, Quality and Regulatory Affairs
Device Name 5.2
Trade or Proprietary Name 5.2.1
Horizon Medical Imaging
5.2.2 Common Name
Horizon Medical Imaging
Classification Name 5.2.3
Picture Archiving and Communications System (per 21 CFR 892.2050).
Devices to which Substantial Equivalence is being Claimed 5.3
| 510(k) Number | Device Name | Manufacturer |
|---|---|---|
| K925965 | Picture Archiving and | |
| Communication Systems | Advanced Light Imaging Technologies | |
| Inc. (now McKesson Medical Imaging | ||
| Company) | ||
| K973959 | O2 Workstation and/or | |
| PACSView software | Olicon Imaging Systems Inc. (now | |
| McKesson Medical Imaging Company) | ||
| K023557 | Centricity PACS Plus | GE Medical Systems |
Horizon Medical Imaging is based on the above identified FDA cleared PACS software of A.L.I. Technologies Inc and Olicon Imaging Systems inc (which A.L.I Technologies Inc acquired in June 1998). A.L.I Technologies Inc. became McKesson Medical Imaging Company in July 2002.
Device Description 5.4
5.4.1 Function
Horizon Medical Imaging is software which when installed and run on Microsoft Windows 2000 and XP operating systems on commercially available IBM PC compatible computers, hardware components and peripherals, forms a medical image and information management system that
1
receives, transmits, stores, retrieves, displays, prints and processes digital medical images, digital receives, transmits, stored, routers, alippy, a promotion medical imaging systems.
Its core components are:
- components are:
High resolution color and grayscale workstations for primary diagnostic interpretation and . secondary review of the medical images, video and related information. - Standard workstations for performing administrative functions of the system .
- Otandard worked in the corporation for short-term and long-term storage of system . data
- Servers for managing the distribution of system data .
- Oct For handing the components for providing the communication channels between the t system's core components and the various medical imaging systems
- system o our ochiponent for producing hardcopy of medical images and related information. .
Scientific Concept 5.4.2
Horizon Medical Imaging is not based upon particular scientific concepts.
Significant Physical and Performance Characteristics 5.4.3
Medical Image and Video Modalities Supported
-
All DICOM 3.0 recognized modalities (specifically including mammographic images) .
Significant Software Features -
User roles and levels of access to patient records and studies .
-
Studies/images management .
-
Patient information management .
-
Actions on studies (e.g. find, open, report, close) .
-
Images and videos displays to user defined display protocols .
-
Image manipulation (e.g. zoom, pan, rotate, flip, window, level, non-linear Look Up Tables) .
-
Image measurements (e.g. distance, area, angle, intensity) .
-
Annotations on images .
-
Receiving images .
-
. Printing images
-
Sending images .
-
Importing/Exporting images .
-
Storing and archiving studies and patient information .
-
Recording, playing, storing and retrieving audio clips .
-
Scanning hardcopy documents; displaying, storing and retrieving electronic versions .
-
Creating, displaying, storing, retrieving accessory information for studies (e.g. notes, diagrams) .
-
DICOM standard approved lossy compression algorithms and file formats (lossy compression not . indicated for mammographic images)
Hardware Reguirements
- Minimum hardware configuration required by Microsoft Windows 2000 and XP, and .
- Minimum hardware configuration indicated by American College of Radiology (in technical . standards on "Digital Image Data Management" and "Teleradiology") for the official diagnostic interpretation of images.
- Mammographic images may only be interpreted using an FDA approved monitor that offers at . least 5 megapixel resolution and meets other technical specifications reviewed and accepted by FDA.
- Only hard copy devices specifically FDA cleared for printing diagnostic quality copies of medical . images are indicated for the official diagnostic interpretation of hard copy medical images printed from Horizon Medical Imaging.
2
5.5 Statement of Intended Use
Horizon Medical Imaging is a medical image and information management system that is intended to rionizon Medical Imaging is a medically, print and process digital medical images, digital medical video, and associated medical information from various medical imaging systems.
The medical modalities of these medical imaging systems include, but are not limited to, all modalities supported by ACR/NEMA DICOM 3.0 (specifically including mammographic images).
Horizon Medical Imaging is intended to connect to a variety of storage systems and printers via DICOM and other computer industry standard interfaces and protocols.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for orimary image interpretations. Mammographic images may only be interpreted using an FDA primaly interprocations: Maint 5 megapixel resolution and meets other technical specifications reviewed and approved by FDA. Horizon Medical Imaging will simply perform normal image manipulations for grayscale and image contrast on mammographic images and will not perform image processing on mammographic images.
Horizon Medical Imaging is indicated for use by trained medical professionals including, but not limited to, radiologists, physicians, and medical technologists. Horizon Medical Imaging is also indicated for use in soft-copy diagnostic interpretation of medical images and video by physicians trained in such practice (specifically including soft-copy diagnostic interpretation of mammographic images).
Comparison of Technological Characteristics 5.6
Horizon Medical Imaging maintains the functionality of the A.L.I. Technologies Picture Archiving and Communication System (K925965) and Olicon Imaging Systems O2 Workstation and/or PACSView software (K973959).
Horizon Medical Imaging adds the intended use of soft-copy official diagnostic interpretation of mammographic images, which is an intended use of the GE Medical Systems Centricity PACS Plus.
In conclusion, Horizon Medical Imaging is substantially equivalent to the GE Medical Systems Centricity PACS Plus for the intended use of soft-copy official diagnostic interpretation of mammographic images.
3
Image /page/3/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" around the edge. Inside the circle is a stylized image of an eagle or bird-like figure. The image is black and white and appears to be a scan or photocopy.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 4 2005
McKesson Medical Imaging Company % Mr. N. E. Devine, Jr. Responsible Third Party Official Entela, Inc. 3033 Madison Ave., SE GRAND RAPIDS MI 49548
Re: K043146 Trade/Device Name: Horizon Medical Imaging Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: 90 LLZ Dated: December 17, 2004 Received: December 20, 2004
Dear Mr. Devine:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we have leviewed your been a verice is substantially equivalent (for the indications for use stated in above and have decorminivarketed predicate devices marketed in interstate commerce prior to the cherosate) to regally manding of the Medical Device Amendments, or to devices that have been May 20, 1970, the enature 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 do not require approval or a provisions of the Act. The general controls provisions of the Act device, subject to the generaliation, 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 If your de roo is classinia ( to such additional controls. Existing major regulations affecting your Apploval), It may oc babyer to ratiFederal Regulations, Title 21, Parts 800 to 898. In addition, FDA as roo blish 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 I lease of advisod 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 I caraft statues and regulating, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) (21 CFR Part 8017), and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed 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.xxxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 892.xxxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmadsmamain.html
Sincerely yours,
Nancy C. brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: Horizon Medical Imaging
Indications For Use:
Horizon Medical Imaging is a medical image and information management system that is intended to Honzon Medical Inflaging is a medical intage und firstmes. I mages, digital medical images, digital medical receive, transmit, store, rothers, acopial in from various medical imaging systems.
The medical modalities of these medical imaging systems include, but are not limited to, all modalities The medical modalities of these mounding mammographic images).
Horizon Medical Imaging is intended to connect to a variety of storage systems and printers via Florizon Medican imaging to industry standard interfaces and protocols.
Lossy compressed mammographic images and digitized film screen images must not be reviewed for Lossy compressed mammographic images and only be interpreted using an FDA primary mage interpretations. Manimographia intagos may only of hereformed in the specifications
approved monitor that offers at least 5 megapixel resolution and meets other approved monition that offers at lead. of mogalities reaging will simply perform normal image reviewed and approved by PDF. Hollen moated images and will not perform image processing on mammographic images.
Horizon Medical Imaging is indicated for use by trained medical professionals including, but not Honzon wedical maging is malbated for aco by frainologists. Horizon Medical Imaging is also ilmitted to, radiologists, physiodins, and notical images and video by physicians Inficated in such sole-copy diagnoule interpretation of mostic interpretation of mammographic images).
Prescription Use
(Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David Ch. Leygon
(Division Sign-Off) Division of Reproductive, Abdor and Radiological Device 510kr Number