(31 days)
90 KPS, LLZ
No Reference Device(s) K/DEN numbers were found in the text.
No
The summary describes image processing and quantitative analysis but does not mention AI, ML, or related terms, nor does it provide details about training or test sets typically associated with AI/ML development.
No
The device is for viewing, quantifying, and processing medical images, not for treating a disease or condition. It is a diagnostic tool, not a therapeutic one.
Yes
The device is used by qualified healthcare providers to view, quantify, and process myocardial perfusion images, and to examine these images for abnormalities and artifacts, which are all steps in reaching a diagnosis. The device also contains optional databases to quantify the extent and severity of myocardial defects, directly aiding in diagnosis.
Yes
The device is described as a "software and computer system" and a "software application installed on laptop computers," with no mention of proprietary hardware components being part of the device itself. While it processes images from SPECT and PET scanners (hardware), the device being reviewed is the software for viewing, quantifying, and processing these images.
Based on the provided information, the ImagenMD™ system is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens from the human body. The ImagenMD™ system processes and displays medical images (SPECT and PET) of the myocardial (heart muscle). It does not analyze biological samples like blood, urine, or tissue.
- The intended use is for viewing, quantifying, and processing images. This is a function related to medical imaging analysis, not laboratory testing of biological specimens.
- The device description focuses on software for image display and analysis. This aligns with medical imaging software, not IVD devices.
Therefore, the ImagenMD™ system falls under the category of medical imaging software, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images. The system, when the QBS option is used, may also be used in the display and analysis of gated short axis blood pool (red blood cells, RBC) SPECT datasets. The system allows the user to view quantify and process perfusion and gated SPECT images.
Product codes
90 KPS, LLZ
Device Description
ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
myocardial perfusion SPECT or PET images, gated short axis blood pool (red blood cells, RBC) SPECT datasets.
Anatomical Site
Myocardium (heart)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians)
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)
Comparison of Technical Characteristics to Predicate Device: The ImagenMD™ system and its predicates, AutoQUANT, QBS and SeeMor have similar indications for use, utilize the same type of data sets for analysis and calculation of data.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
AutoQUANT, SeeMor, QBS
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1200 Emission computed tomography system.
(a)
Identification. An emission computed tomography system is a device intended to detect the location and distribution of gamma ray- and positron-emitting radionuclides in the body and produce cross-sectional images through computer reconstruction of the data. This generic type of device may include signal analysis and display equipment, patient and equipment supports, radionuclide anatomical markers, component parts, and accessories.(b)
Classification. Class II.
0
KO41671
JUL 2 2 2004
VII. 510-(k) Summary
This summary of 510(k) safety and effectiveness information is submitted in accordance with 21 CFR 807.92.
General Information:
| A. | Submitted By: | Cardiovascular Imaging Technologies
4320 Wornall Road, Suite 55
Kansas City, MO 64111
Tel: 816-531-2842
Fax: 816-531-0643 |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James A. Case |
| B. | Device Trade Name: | ImagenMD™ |
| | Classification Name: | System, Emission Computed Tomography |
| C. | Predicate Devices: | AutoQUANT -- ADAC Laboratories
SeeMor -- Areeda Associates
QBS - ADAC Laboratories |
D. Device Description:
ImagenMD™ is a software application installed on laptop computers which allows physicians and healthcare professionals to view myocardial perfusion SPECT or PET images from their office, hospital or home. The system processes perfusion and gated SPECT performing quantitative data analysis. The user can select raw, short axis, transmission slice and gated short axis studies for the purpose of examining those images for abnormalities and artifacts. The system contains optional databases which quantify the extent and severity of myocardial defects. Also included is an application for the display and analysis of gated short axis blood pool SPECT datasets. Use of this system is limited to qualified, licensed healthcare providers (radiologists, nuclear cardiologists or nuclear medicine physicians) trained in the use of nuclear medicine imaging devices. f
E. Indications for Use:
The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images. The system, when the QBS option is used, may also be used in the display and analysis of gated short axis
1
blood pool (red blood cells, RBC) SPECT datasets. The system allows the user to view quantify and process perfusion and gated SPECT images.
-
Comparison of Technical Characteristics to Predicate Device: F.
The ImagenMD™ system and its predicates, AutoQUANT, QBS and SeeMor have similar indications for use, utilize the same type of data sets for analysis and calculation of data. -
Summary: H.
Testing and comparison of technological characteristics and intended uses found that all components of the ImagenMD™
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 22 2004
Cardiovascular Imaging Technologies % Ms. Melanie Hasek Sr. Regulatory Affairs Specialist Regulatory/Clinical Consultants, Inc. 200 NE Mulberry LEE'S SUMMIT MO 64086
Re: K041671
Trade/Device Name: ImagenMD™ Computer System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulatory Name: Picture archiving and Communications system Regulatory Class: II Product Code: 90 KPS and LLZ Dated: June 18, 2004 Received: June 21, 2004
Dear Ms. Hasek:
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 (PMA), 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.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination 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 Act's requirements, including, 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) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
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 the letter:
| 8xx.1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion 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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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/dsma/dsmamain.html.
Sincerely yours,
Nancy C. Brigdon
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
510(k) Number (if known): K041671_
Device Name: ______ ImagenMD IM
Indications for Use:
The ImagenMD™ system is a software and computer system that allows the user to view
the system the contrained and increase from a remote location. The system allows The ImagenMD ™ system is a sortware and computer a for and on and one of the system allows
myocardial perfusion SPEC or PBT inages from a remote location. The system allows myocardial perfusion SPEC of FDT images from and gated SPECT images.
the user to view quantify and process perfusion and gated SPECT images.
X 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
) (PLEASE DO NOT WRITE BELOW OF NECEDED) OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
David A. Lipson
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number _
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