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Found 5 results
510(k) Data Aggregation
K Number
K153056Device Name
Hermes Medical Imaging Suite v5.6
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2016-06-01
(224 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HERMES MEDICAL SOLUTIONS, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HERMES Medical Imaging Suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquistion stations.
Device Description
The Hermes Medical Imaging Suite provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
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K Number
K142631Device Name
Hermes Medical Imaging Suite v5.5
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2014-12-18
(92 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HERMES MEDICAL SOLUTIONS, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HERMES Medical Imaging suite that provides software applications used to process, display, and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Device Description
The base product design of Hermes Medical Imaging Suite v5.5 is the same as for the Hermes Medical Imaging Suite v5.4 (K140269). A modification has been made in the reconstruction software Hybrid Recon™ where a new feature is added to enable quantitative reconstruction. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
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K Number
K140269Device Name
HERMES MEDICAL IMAGING SUITE V5.4
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2014-05-08
(94 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HERMES MEDICAL SOLUTIONS, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Device Description
The base product design of Hermes Medical Imaging Suite v5.4 is the same as for the Hermes Medical Imaging Suite v5.3 (K131233). A modification has been made of the product where the imaging processing application BRASS™ has been transferred from the Oracle® Solaris environment to the Microsoft® Windows environment. BRASS™ has also been updated with improved support for management and analysis of amyloid PET imaging as described in the 510(k) submission. The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.
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K Number
K131233Device Name
HERMES MEDICAL IMAGING SUITE V5.3
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2013-07-16
(76 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HERMES MEDICAL SOLUTIONS, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HERMES Medical Imaging suite that provides software application used to process, display, analyze and manage nuclear medical imaging data transferred from other workstation or acquisition stations.
Device Description
The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Ask a Question
K Number
K121278Device Name
HERMES MEDICAL IMAGING SUITE V5.2
Manufacturer
HERMES MEDICAL SOLUTIONS, AB
Date Cleared
2012-12-18
(232 days)
Product Code
KPS
Regulation Number
892.1200Why did this record match?
Applicant Name (Manufacturer) :
HERMES MEDICAL SOLUTIONS, AB
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
HERMES Medical Imaging suite that provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Device Description
The Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstation or acquisition stations.
Ask a Question
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