(125 days)
Not Found
No
The description focuses on basic image display, manipulation, and export functionalities, with no mention of AI, ML, or related concepts like automated analysis, pattern recognition, or learning algorithms. The technology described is consistent with standard image viewing software from the era of floppy disks and CD-ROMs.
No
The device is a display and review system for X-ray cardiac angiography images, primarily for viewing and manipulating images, not for providing therapy or treatment.
No
The device is described as an image display and review system for X-ray cardiac angiography results, allowing users to view, change the appearance of, and export images. It does not perform analysis or provide diagnostic interpretations itself.
Yes
The device is explicitly described as a "computer program" and "software program" provided on a floppy disk, with no mention of accompanying hardware components required for its primary function of displaying and reviewing images.
Based on the provided information, the ImageView™ Coronary Angiography Display and Review System 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. They are used to provide information for diagnosis, monitoring, or screening.
- ImageView™ Function: The ImageView™ system is a software program designed to view and manipulate digital images obtained from an X-ray cardiac angiography procedure. This procedure involves imaging the inside of blood vessels using X-rays and contrast dye, which is an in vivo (within the living body) imaging technique, not an in vitro test.
- No Sample Analysis: The system does not analyze biological samples or perform any tests on substances taken from the body. Its function is solely related to the display and processing of medical images.
Therefore, the ImageView™ system falls under the category of medical imaging software, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
Product codes
90 IZI
Device Description
The ImageView™ Coronary Angiography Display and Review System is an angiographic image review software program. It is provided on a 3½-inch 1.44 MB floppy disk. The disk contains the installation program, ImageView™ executable files, a Readme file and Dynamic Link Library files. ImageView™ is designed to read and display angiographic images which have been stored using the DICOM 3.0 format for medical images.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
X-ray
Anatomical Site
cardiac
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
§ 892.1600 Angiographic x-ray system.
(a)
Identification. An angiographic x-ray system is a device intended for radiologic visualization of the heart, blood vessels, or lymphatic system during or after injection of a contrast medium. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
4972229
510(k) Summary
for
OCT 16 1997
ImageView™ Coronary Angiography Display and Review System
Applicant 1.
HeartWare, Inc. Laurston Court Durham, NC 27712
Laurence A. Spero Contact Person: 919-471-6613 Telephone:
June 12, 1997 Date Prepared:
Device Name 2.
ImageView™ Coronary Angiography Display and Review Proprietary Name: System
Cardiac Image Review Software Common Name:
Accessory to Angiographic X-Ray Systems Classification Name:
Class II Classification Status:
Predicate Devices 3.
.
- DICOMview™ . Heartlab, Inc. K954479
- Kodak Digital Science Cardiac Review Station CRS 2000 Jamieson Film Co. K960043
1
Device Description 4.
The ImageView™ Coronary Angiography Display and Review System is an angiographic image review software program. It is provided on a 3½-inch 1.44 MB floppy disk. The disk contains the installation program, ImageView™ executable files, a Readme file and Dynamic Link Library files. ImageView™ is designed to read and display angiographic images which have been stored using the DICOM 3.0 format for medical images.
5. Intended Use
The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
Technological Characteristics 6.
The ImageView™ Coronary Angiography Display and Review System is intended for the same general purposes as the predicate devices identified above. The functional performance of all of the devices is comparable. The ImageView™ System and the predicate devices employ graphical user interfaces to perform the necessary functions required to display and review a DICOM image record. All systems access images from a DICOM CD and can display images either directly from the CD or by loading the images into RAM for improved performance.
2
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the caduceus symbol. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Cynthia A. Sinclair Senior Staff Consultant Heartware, Inc. c/o Medical Device Consultants, Inc. 49 Plain St. North Attleboro, MA 02760
Re:
ImageView Coronary Angiography Display and Review System (Cardiac Device Accessory) Dated: September 25, 1997 Received: September 26, 1997 Regulatory class: II 21 CFR 892.1600/Procode: 90 IZI
Dear Ms. Sinclair:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours
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Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
510(k) Number (if known): __
Device Name: ImageView™ Coronary Angiography Display and Review System_
Indications For Use:
The ImageView™ Coronary Angiography Display and Review System is a computer program which can be used to view the results of an X-ray cardiac angiography procedure on a personal computer workstation. The digital image record of the X-ray exposures made during a catheterization procedure can be retrieved from a compact disk (CD) and displayed on a computer workstation monitor. ImageView™ also allows the user to change the appearance of the images and export selected frames to other programs for printing and further manipulation.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Vain L. Seppanen
Division of Reproductive, Abdominal, ENT and Radiological Device 510(k) Number
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use
(Optional Format 1-2-96)
HeartWare ImageView 510(k)
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