D-SPECT VISTA 8010267-01

GUDID 00729018670141

Single Photon Emission Computed Tomography System, 230V

SPECTRUM DYNAMICS MEDICAL, INC

SPECT system, annular detector array

• Primary Device ID: 00729018670141
• NIH Device Record Key: b3b591ca-51c4-43a5-98e0-976c014dc95b
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: D-SPECT VISTA
• Version Model Number: 002
• Catalog Number: 8010267-01
• 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	00729018670141 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K161740

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: 2020-07-06
• Device Publish Date: 2020-06-28

On-Brand Devices [D-SPECT VISTA]

• 00729018670141: Single Photon Emission Computed Tomography System, 230V
• 07290108670134: Single Photon Emission Computed Tomography System, 110 V
• 07290108670141: Single Photon Emission Computed Tomography System, 230V