VERITON NM 8010184-01

GUDID 07290108670103

Single Photon Emission Computed Tomography System

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array

• Primary Device ID: 07290108670103
• NIH Device Record Key: f34b1d28-1aff-419c-8178-894310d5a2c2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: VERITON NM
• Version Model Number: 001
• Catalog Number: 8010184-01
• 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	07290108670103 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180514

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: 2018-12-10
• Device Publish Date: 2018-11-08

On-Brand Devices [VERITON NM]

• 07290108670103: Single Photon Emission Computed Tomography System
• 07290108670240: Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION
• 07290108670202: Single Photon Emission Computed Tomography System WITH ‘TOTAL BODY’ ACQUISITION