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510(k) Data Aggregation
K Number
K042692Device Name
CLARITY FUSION
Manufacturer
Date Cleared
2004-10-07
(7 days)
Product Code
Regulation Number
892.2050Why did this record match?
Applicant Name (Manufacturer) :
SHARED P.E.T. IMAGING, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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.
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K Number
K032866Device Name
CLARITY PET
Manufacturer
Date Cleared
2003-12-12
(88 days)
Product Code
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
SHARED P.E.T. IMAGING, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
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 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
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