IMAGENPRO

K050366 · Cardiovascular Imaging Technologies, LLC · KPS · Mar 17, 2005 · Radiology

Device Facts

• Record ID: K050366
• Device Name: IMAGENPRO
• Applicant: Cardiovascular Imaging Technologies, LLC
• Product Code: KPS · Radiology
• Decision Date: Mar 17, 2005
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT rcconstructed tomograms.

Device Story

ImagenPRO™ is a desktop software application for processing myocardial perfusion PET and PET/CT data. It accepts raw emission and transmission data as input. The system performs image reconstruction and reorientation, allowing users to select correction parameters, filter settings, and reconstruction ranges to generate 3D tomographic data. It is intended for use by radiologists, nuclear cardiologists, or nuclear medicine physicians in clinical settings. Physicians use the output to inspect and analyze myocardial perfusion, aiding in clinical assessment of cardiac function. The device facilitates diagnostic workflows by providing tools for visualization and image manipulation.

Clinical Evidence

No clinical data provided; substantial equivalence is based on technological comparison and bench testing.

Technological Characteristics

Software application for desktop computers. Processes raw PET/CT emission and transmission data. Functions include image reconstruction, filtering, and reorientation. No specific hardware or material standards cited.

Indications for Use

Indicated for use by qualified, licensed healthcare providers (radiologists, nuclear cardiologists, or nuclear medicine physicians) to visualize, reconstruct, and reorient myocardial perfusion PET or PET/CT images from raw emission and transmission data.

Regulatory Classification

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.

Predicate Devices

• Siemens/CTI Accel -- CPS Innovations (K002584)
• GE Discovery LS - General Electric (K023988)

Submission Summary (Full Text)

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K050366

MAR 1 7 2005

## 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<br>4320 Wornall Road, Suite 55<br>Kansas City, MO 64111<br>Tel: [phone]<br>Fax: [phone] |
|----|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| | Contact Person: | James A. Case |
| B. | Device Trade Name: | ImagenPRO™™ |
| | Classification Name: | System, Emission Computed Tomography |
| C. | Predicate Devices: | Siemens/CTI Accel -- CPS Innovations - K002584<br>GE Discovery LS - General Electric - K023988 |

#### D. Device Description:

ImagenPRO™ is a software application installed on desktop computers which allows physicians and healthcare professionals to inspect, reconstruct and reorient myocardial perfusion PET images. The system processes perfusion and gated PET raw emission and transmission data to create 3D tomographic data. The user can select correction parameters, filter setting, range of reconstruction, and reorientation angles. 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.

- E. Indications for Use:
The ImagenPRO™ system is a software and/or computer system that allows the user to visualize raw PET and/or PET/CT data, reconstruct myocardial perfusion PET or PET/CT images and reorient PET and/or PET/CT rcconstructed tomograms.

- F. Comparison of Technical Characteristics to Predicate Device:
The ImagenPRO™ system and its predicates, the Siemens e.cat and the GE Discovery LS utilize the same type of data sets for analysis and calculation of data.

Page 71 of 99

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#### Summary: H.

Testing and comparison of technological characteristics and intended uses found that all resting and companison of won™ system are equivalent to the predicates.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo is circular and contains an abstract image of an eagle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circle.

Public Health Service

MAR 1 7 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Cardiovascular Imaging Technologies % Ms. Melanie Hasek Sr. Regulatory Affairs Specialist Regulatory/Clinical Consultants, Inc. 200 NE Mulberry LEE'S SUMMIT MO 64086

Re: K050366

Trade/Device Name: ImagenPROTM System Regulation Number: 21 CFR 892.1200 Regulation Name: Emission computed tomography system Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system Regulatory Class: II Product Code: KPS and LLZ Dated: February 14, 2005 Received: February 14, 2005

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 (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.

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 (Scctions 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) Fills letter with and in you've organ and cquivalence of your device of your device to a legally prematice nodicate 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 If you desire specific act 100 for your as 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 007. 77. " ou may obtain varers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/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

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# I. Indications for Use:

Indications for Use Form

Page 1 of 1

510(k) Number (if known): K150366

Device Name: ImagenPRO™

Indications For Use:

The ImagenPRO™ system is software that allows the user to visualize raw PET and/or The Indigent RO - System is beforeial perfusion PET or PET/CT images and reorient PET and/or PET/CT reconstructed tomograms.

*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 OF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadon

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number K0503(da