CLARITY PET

K032866 · Shared P.E.T. Imaging, LLC · KPS · Dec 12, 2003 · Radiology

Device Facts

• Record ID: K032866
• Device Name: CLARITY PET
• Applicant: Shared P.E.T. Imaging, LLC
• Product Code: KPS · Radiology
• Decision Date: Dec 12, 2003
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 892.1200
• Device Class: Class 2
• Attributes: Software as a Medical Device

Intended Use

To detect or image the distribution of radionuclides in the body or organ, using the following techniques: Multiplanar Reconstruction (MPR) . Maximum/Minimum Intensity Projection (MIP) . Image Contrast Manipulation . Image Zoom Manipulation . Automatic registration with Mutual Information Technique .

Device Story

Clarity PET is a medical diagnostic workstation software for display, review, 3D multiplanar reconstruction (MPR), communication, and archiving of medical images. It accepts various manufacturer image formats and DICOM-formatted images. The device performs image processing tasks including maximum/minimum intensity projection (MIP), contrast manipulation, zoom manipulation, and automatic image registration using mutual information techniques. It operates on the Microsoft Windows platform. Used in clinical settings, the software serves as an aid to physicians for image interpretation; it does not provide a final diagnosis but integrates into the physician's clinical workflow to assist in forming a final interpretation. It benefits patients by facilitating the review and analysis of PET imaging data.

Clinical Evidence

No clinical data provided. The device relies on bench testing and demonstration of substantial equivalence to predicate devices for image processing and display functionality.

Technological Characteristics

Software-based medical image workstation. Supports DICOM and various manufacturer-specific image formats. Operates on Microsoft Windows OS. Features include 3D MPR, MIP, image contrast/zoom manipulation, and automatic registration via mutual information technique.

Indications for Use

Indicated for the detection or imaging of radionuclide distribution in the body or organs for diagnostic review.

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

• Medical Image Merge (K001276)

Reference Devices

• Syngo Multi-Modality Workstation (K010938)
• ADAC Laboratories Image Fusion and Review System (K973233)
• GE Advantage Windows Workstation (K960613)

Submission Summary (Full Text)

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K032866

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# 7.0 PREMARKET NOTIFICATION 510(K) SUMMARY

Sponsor:

Shared P.E.T. Imaging, LLC 4912 Higbee Ave.NW, Ste 100 Canton OH 44718 Telephone: [phone] Fax: [phone] Contact: Randy W. Skiles, CEO

Registration:

To be assigned

Clarity PET Trade Name of Device: Clarity PET Common Name: System, Image Processing, Radiological Classification name: LLZ Product Code: II Regulation Class: 8892.2050 Regulation Number:

# Device Description and Intended Use: .

Clarity PET is PET intage review software. Clarity PET offers a comprehensive software solution for medical imaging tasks and applications. Clarity PET is a medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images

### Technological Characteristics: .

The Clarity PET Device supports various medical image manufacturer's image format and DICOM formatted images. Clarity PET is designed to run on the Microsoft Windows family of operating systems

#### General Safety and Effectiveness Concerns: .

The device labeling contains instructions for use and any necessary cautions and warning, to provide for safe and effective use of the device. Serving primarily as an aid in image display, this device has no direct adverse effect on health as the results are to be integrated into all of the information a physician will use to form a final interpretation.

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#### Marketing History .

Clarity PET performs the same functions as several other medical device image programs marketed in the past. Some of the programs are Medical Image Merge(K001276), Syngo Multi-Modality Workstation(K010938), ADAC Laboratories Image Fusion and Review System(K973233) and the GE Advantage Windows Workstation(K960613). All of the aforementioned devices are used to display medical images from multiple modalities in multiple image formats.

- Substantial Equivalence: .
- The Shared PET Imaging Clarity PET has indications for use equivalent to those for . the Medical Image Merge™ device.
- The Shared PET Imaging Clarity PET has technological characteristics, performance . characteristics, and instructions for use equivalent to those for the Medical Image Merge™ device.

# 510(k) Cleared Indications for Use: .

To detect or image the distribution of radionuclides in the body or organ, using the following techniques:

- Multiplanar Reconstruction (MPR) .
- Maximum/Minimum Intensity Projection (MIP) .
- Image Contrast Manipulation .
- Image Zoom Manipulation .
- Automatic registration with Mutual Information Technique .

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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 consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# DEC 1 2 2003

Shared P.E.T. Imaging, LLC % Russ Pagano, Ph.D. M Squared Associates, Inc. 719 A Street, NE WASHINGTON DC 20002

Re: K032866 Trade/Device Name: Clarity PET 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: 90 KPS and LLZ Dated: September 12, 2003 Received: September 15, 2003

Dear Dr. Pagano:

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. Ilisting 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 | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [phone] |

Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely vours.

Nancy C. bogden

Nancy C. Brogdor Director, Division of Reproductive. Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page 1 of 1

5 10(k) Number (if known): K.032866

Device Name: Clarity PET

Indications for Use:

To detect or image the distribution of radionuclides in the body or ergan, using the following techniques:

- Multiplanar Reconstruction (MPR) .
- Maximum/Minimum Intensity Projection (MIP) .
- Image Contrast Manipulation .
- Image Zoom Manipulation *
- Automatic registration with Mutual Information Technique .

(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED):

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use do
(Per 21 CFR 801.109) the The Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number

| Labels | Values |
|---------------|---------|
| 510(k) Number | K032866 |