AnyScan

GUDID 05999884132172

SPECT Imaging System

MEDISO Kft.

SPECT system, rotating detector head

• Primary Device ID: 05999884132172
• NIH Device Record Key: eb69c3b7-ad0f-4d43-be6c-cd675780a12c
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: AnyScan
• Version Model Number: AnyScan S
• Company DUNS: 401469804
• Company Name: MEDISO Kft.
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	05999884132172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K131625

FDA Product Code

• KPS: System, Tomography, Computed, Emission

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2016-09-23