Hermes Medical Imaging Suite P0

GUDID 00859873006158

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.

Hermes Medical Solutions AB

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• Primary Device ID: 00859873006158
• NIH Device Record Key: b2a63827-5be7-4a4c-8070-3d44841bbe45
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Hermes Medical Imaging Suite
• Version Model Number: 6
• Catalog Number: P0
• Company DUNS: 354140220
• Company Name: Hermes Medical Solutions AB
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: false
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	00859873006158 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K171681

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2022-02-15
• Device Publish Date: 2022-02-07

Devices Manufactured by Hermes Medical Solutions AB

• 00859873006172 - Affinity: 2023-07-11 Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and ana
• 00859873006158 - Hermes Medical Imaging Suite: 2022-02-15Hermes 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.
• 00859873006158 - Hermes Medical Imaging Suite: 2022-02-15 Hermes Medical Imaging Suite provides software applications used to process, display, analyze and manage nuclear medicine and ot
• 00859873006165 - Affinity: 2022-02-15 AFFINITY is a software application used to process, display, analyze and manage nuclear medicine and other medical imaging data
• 00859873006141 - Affinity: 2021-01-19 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
• 00859873006134 - Affinity: 2020-03-04 AFFINITY is a software application used to process, display, analyse and manage nuclear medicine and other medical imaging data
• 00859873006110 - Voxel Dosimetry: 2019-12-10 Voxel Dosimetry™ is a tool for voxel level absorbed dose calculation resulting from radiotracer injection. Voxel Dosimetry™
• 00859873006035 - OLINDA/EXM: 2018-07-06 The intended use of OLINDA/EXM is to provide estimates (deterministic) of absorbed radiation dose at the whole organ level as a
• 00859873006059 - HMS Medical Imaging Suite: 2018-07-06 HMS Medical Imaging Suite that provides software applications used to process, display, analyze and manage nuclear medicine and