(7 days)
Not Found
No
The summary describes standard image processing techniques and image fusion, which are not inherently AI/ML. There is no mention of AI, ML, or related concepts like training or test sets.
No.
The device is used to detect/image radionuclides for diagnostic purposes, not to treat a disease or condition.
Yes
This device is for detecting or imaging the distribution of radionuclides in the body or organs, which are diagnostic activities. It allows a physician to look at fused images from different modalities to assess the patient's condition.
No
The device is described as an "option within the Clarity PET system" and processes images from different modalities, implying it relies on hardware (the PET system and potentially other imaging modalities) to acquire the initial data. While the fusion and viewing capabilities are software-based, the device's function is intrinsically linked to and dependent on hardware for data input.
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 the device is used to "detect or image the distribution of radionuclides in the body or organ." This involves imaging the body directly, not analyzing samples taken from the body.
- Techniques Used: The listed techniques (MPR, MIP, Image Contrast/Zoom Manipulation, Automatic registration) are all image processing and visualization techniques applied to medical images acquired from within the body.
- Device Description: The description of Clarity Fusion as an option within a PET system for viewing fused images from different modalities further reinforces its role in medical imaging, not in vitro testing.
Therefore, this device falls under the category of medical imaging devices, not in vitro diagnostics.
N/A
Intended Use / 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
- Automatic registration with Mutual Information Technique .
Product codes
LLZ
Device Description
Clarity Fusion is an option within the Clarity PET system so the end-user may differentiate between the two different applications within the same software program. This viewing of fused images is the ability to see the same datasets, as if they were being viewed independently, overlapped with each others. These fused images will allow a physician to look at two different datasets from different modalities. This is common medical practice that has now been computerized.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Body or organ
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.2050 Medical image management and processing system.
(a)
Identification. A medical image management and processing system is a device that provides one or more capabilities relating to the review and digital processing of medical images for the purposes of interpretation by a trained practitioner of disease detection, diagnosis, or patient management. The software components may provide advanced or complex image processing functions for image manipulation, enhancement, or quantification that are intended for use in the interpretation and analysis of medical images. Advanced image manipulation functions may include image segmentation, multimodality image registration, or 3D visualization. Complex quantitative functions may include semi-automated measurements or time-series measurements.(b)
Classification. Class II (special controls; voluntary standards—Digital Imaging and Communications in Medicine (DICOM) Std., Joint Photographic Experts Group (JPEG) Std., Society of Motion Picture and Television Engineers (SMPTE) Test Pattern).
0
PREMARKET NOTIFICATION SPECIAL 510(K) SUMMARY 8
Sponsor:
Shared P.E.T. Imaging, LLC 4912 Higbee Avenue NW. Ste 100 Canton OH 44718 Telephone: (330) 491-0480 Fax: (330) 491-0488 Contact: Marc A. Simms, Director of Information Technology
| Proprietary Name: | Clarity Fusion |
|---|---|
| Common Name: | Clarity Fusion |
| Classification Name: | System, Image Processing, Radiological |
| Reference Number: | §892.2050 |
| Owner/Operator Number: | 9056369 |
| Establishment Registration | |
| Number: | 3004082056 |
| Listing Status: | Active |
| Proposed Regulatory Class: | Class II |
| Device Product Code: | LLZ |
| Panel / Code: | Radiology |
| Reason for Special 510(k): | Establish Substantial Equivalence to a previously marketed predicate |
| device, Clarity PET. The Clarity PET (K032866) is also | |
| manufactured by Shared PET Imaging. This SPECIAL 510(k) | |
| merely adds a module to Clarity PET for enhanced diagnostic image | |
| quality. The intended use and indications for are not changed from | |
| the original 510(k) |
1
. Device Description and Intended Use:
Clarity Fusion is an option within the Clarity PET system so the end-user may differentiate between the two different applications within the same software program. This viewing of fused images is the ability to see the same datasets, as if they were being viewed independently, overlapped with each others. These fused images will allow a physician to look at two different datasets from different modalities. This is common medical practice that has now been computerized.
. 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.
Substantial Equivalence: .
As required for a special 510(k), the Clarity Fusion has the identical indications as the Clarity PET and software validation/verification and a Declaration of Conformity were submitted to demonstrate substantial equivalence.
. 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
- 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 & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its wings or body. The bird is positioned to the left of the text, which is arranged in a circular pattern around the logo. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA".
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 7 - 2004
'Shared P.E.T. Imaging, LLC % Mr. Russ Pagano Official Correspondent M Squared Associates, Inc. 719 A Street, NE WASHINGTON DC 20002 Re: K042692
Trade/Device Name: Clarity Fusion Regulation Number: 21 CFR 892.2050 Regulation Name: Picture archiving and communications system
Regulatory Class: II Product Code: 90 LLZ Dated: September 29, 2004 Received: September 30, 2004
Dear Mr. Pagano:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced we nave reviewed four courte is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to the encreated of the enactment date of the Medical Device Amendments, or to devices that have been rear 20, 1770, 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 do not require approval controls provisions of the Act. The general controls provisions of the Act include reguirements 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 " 11 your do roo to subject to such additional controls. Existing major regulations affecting your Apploral), It they 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 statues and regulations administered by other Federal agencies. You must comply with all the I oc '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 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 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/cdrb/dsmadsmamain.html
Sincerely yours,
Nancy C. Brogdon
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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Page 1 of 1
K042692 510(k) Number (if known): Device name: Clarity Fusion 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 .
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) CONCURRENCE OF cdrh, Office of Device Evaluation (ODE)
Prescription use _X (Per 21 CFR801.109) OR
Over-the Counter use (Optional format 1-2-96)
Nancy C. Boughton
510(k) Number