PHOTONVUE

GUDID B475PVUEC0A1V100

optical head

FLUOPTICS

Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital Stationary general-purpose fluoroscopic x-ray system, digital

• Primary Device ID: B475PVUEC0A1V100
• NIH Device Record Key: 57627321-cbb0-482c-84c4-18500384d6b6
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PHOTONVUE
• Version Model Number: PVUEC0A1 V1.0
• Company DUNS: 260631677
• Company Name: FLUOPTICS
• 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
HIBCC	B475PVUEC0A1V100 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K132475

FDA Product Code

• OWN: Confocal Optical Imaging

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-07-06
• Device Publish Date: 2017-04-27

On-Brand Devices [PHOTONVUE]

• B475PVUEC0A2V100: control box
• B475PVUEC0A1V100: optical head