(88 days)
No
The summary describes standard image processing techniques (MPR, MIP, contrast, zoom, automatic registration with Mutual Information) and a medical diagnostic workstation for image review and archiving. There is no mention of AI, ML, deep learning, or any related concepts. The listed predicate devices are also standard image processing and workstation systems.
No.
The device is used for image review and processing to detect or image the distribution of radionuclides, which is a diagnostic function, not a therapeutic one.
Yes
The "Intended Use" states "To detect or image the distribution of radionuclides in the body or organ", and the "Device Description" states "Clarity PET is a medical diagnostic workstation". Both directly indicate a diagnostic purpose.
Yes
The device is described as "PET image review software" and a "medical diagnostic workstation designed for display, review, 3D MPR, communication and archiving of medical images." This description focuses solely on software functionalities for image processing and management, without mentioning any associated hardware components that are part of the device itself.
Based on the provided information, this device 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.
- Device Function: The description clearly states that Clarity PET is "PET image review software" used to "detect or image the distribution of radionuclides in the body or organ." It processes and displays images obtained from a PET scanner, which is an in-vivo imaging modality (performed on a living organism).
- Lack of Sample Analysis: There is no mention of analyzing biological samples or performing tests on substances taken from the body.
Therefore, Clarity PET falls under the category of medical imaging software, not an in vitro diagnostic device.
N/A
Intended Use / 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 .
Product codes
LLZ, KPS
Device Description
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
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
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
PET
Anatomical Site
body or organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical diagnostic workstation
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)
Medical Image Merge(K001276)
Reference Device(s)
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
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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: (330) 491-0480 Fax: (330) 491-0488 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 .
2
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.
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 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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4
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 |