Affinity P60

GUDID 00859873006165

AFFINITY is a software application used to process, display, analyze and manage nuclear medicine and other medical imaging data transferred from other workstations, PACS or acquisition stations. The information acquired from viewing the images is used, in conjunction with other patient related data, for diagnosis and monitoring of disease.

Hermes Medical Solutions AB

Nuclear medicine system workstation

• Primary Device ID: 00859873006165
• NIH Device Record Key: 1a6c2eec-d09a-43d2-aed2-3c645ee1413b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Affinity
• Version Model Number: 3
• 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: 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	00859873006141 [Previous]
GS1	00859873006165 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K202882

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

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