The ImagenMD™ system is a software and computer system that allows the user to view myocardial perfusion SPEC or PET images from a remote location. The system allows the user to view quantify and process perfusion and gated SPECT images.

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.

AI/ML Overview

The provided document does not contain information regarding a specific study with acceptance criteria and reported device performance. It is a 510(k) summary for the ImagenMD™ system, which primarily focuses on establishing substantial equivalence to predicate devices rather than presenting detailed clinical trial results or performance metrics against defined acceptance criteria.

The document describes the device, its indications for use, and compares its technical characteristics to predicate devices (AutoQUANT, SeeMor, QBS). It does not include:

A table of acceptance criteria and reported device performance.
Sample sizes used for a test set or data provenance.
Number of experts and their qualifications for ground truth establishment.
Adjudication methods.
Multi-reader multi-case (MRMC) comparative effectiveness study results or effect sizes.
Standalone (algorithm only) performance study details.
The type of ground truth used (e.g., pathology, outcomes data).
Sample size for the training set.
How ground truth for the training set was established.

The document is a regulatory submission for premarket notification (510(k)), which typically demonstrates equivalence to existing legally marketed devices rather than providing the detailed clinical study data often found in PMA submissions or peer-reviewed publications.

Summary

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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 Technologies4320 Wornall Road, Suite 55Kansas City, MO 64111Tel: 816-531-2842Fax: 816-531-0643
	Contact Person:	James A. Case
B.	Device Trade Name:	ImagenMD™
	Classification Name:	System, Emission Computed Tomography
C.	Predicate Devices:	AutoQUANT -- ADAC LaboratoriesSeeMor -- Areeda AssociatesQBS - ADAC Laboratories

D. Device Description:

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

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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.

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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 _

Page _1_of 1

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Regulation Number and Section

§ 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.