PositView

GUDID 04540217072798

SHIMADZU CORPORATION

PET system

• Primary Device ID: 04540217072798
• NIH Device Record Key: dac4681e-56a9-4d5b-a577-c15831e333f9
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PositView
• Version Model Number: 567-11700-13
• Company DUNS: 690558747
• Company Name: SHIMADZU CORPORATION
• 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: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
GS1	04540217072798 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K240827

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: 2025-05-26
• Device Publish Date: 2025-05-16

Devices Manufactured by SHIMADZU CORPORATION

• 04540217040872 - SONIALVISION G4: 2025-05-28
• 04540217040889 - SONIALVISION G4: 2025-05-28
• 04540217040896 - SONIALVISION G4: 2025-05-28
• 04540217041022 - SONIALVISION G4: 2025-05-28
• 04540217041039 - SONIALVISION G4: 2025-05-28
• 04540217041046 - SONIALVISION G4: 2025-05-28
• 04540217041053 - SONIALVISION G4: 2025-05-28
• 04540217041060 - SONIALVISION G4: 2025-05-28