VERITON CT 8010421-01

GUDID 07290108670172

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

SPECTRUM DYNAMICS MEDICAL, INC

SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system SPECT/CT system

• Primary Device ID: 07290108670172
• NIH Device Record Key: 6fb2cdb9-9ddb-49c7-87d2-26f971c8ec75
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERITON CT
• Version Model Number: VERITON CT 416
• Catalog Number: 8010421-01
• 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	07290108670172 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K230600

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: 2023-06-09
• Device Publish Date: 2023-06-01

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• 07290108670172: Single Photon Emission Computed Tomography System combined with a Computed Tomography (CT) syste