VERITON CT 8010142-01

GUDID 07290108670110

Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) system for x-ray imaging,

SPECTRUM DYNAMICS MEDICAL, INC

SPECT/CT system

• Primary Device ID: 07290108670110
• NIH Device Record Key: c7523863-99f5-4d61-ad2a-05c3cd05ef8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERITON CT
• Version Model Number: VERITON CT 64
• Catalog Number: 8010142-01
• Company DUNS: 078864620
• Company Name: SPECTRUM DYNAMICS MEDICAL, INC
• 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: 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	07290108670110 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182484

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2019-01-11
• Device Publish Date: 2018-12-11

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