Affinity P60

GUDID 00859873006172

Affinity is a software application for nuclear medicine and radiology. Based on user input, Affinity processes, displays and analyzes nuclear medicine and radiology imaging data and presents the results to the user. The results can be stored for future analysis. The software application can be configured based on user needs. The investigation of physiological or pathological states using measurement and analysis functionality provided by Affinity is not intended to replace visual assessment. The information obtained from viewing and/or performing quantitative analysis on the images is used, in conjunction with other patient related data, to inform clinical management.

Hermes Medical Solutions AB

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• Primary Device ID: 00859873006172
• NIH Device Record Key: d139de4a-7529-41af-a343-932f735b7eb7
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity
• Version Model Number: 4.0
• Catalog Number: P60
• 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: true
• Manufacturing Date: false
• 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	00859873006165 [Previous]
GS1	00859873006172 [Primary]

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: 2023-07-11
• Device Publish Date: 2023-07-03

On-Brand Devices [Affinity]

• 00859873006134: AFFINITY is a software application used to process, display, analyse and manage nuclear medicine
• 00859873006141: AFFINITY is a software application used to process, display, analyse and manage nuclear medicine
• 00859873006165: AFFINITY is a software application used to process, display, analyze and manage nuclear medicine
• 00859873006172: Affinity is a software application for nuclear medicine and radiology. Based on user input, Affi