Genoray

GUDID 08809244061189

GENORAY CO., LTD.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08809244061189
• NIH Device Record Key: aaa6939b-5e08-4761-8be0-cc9a8bdd67a2
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genoray
• Version Model Number: Suni Q3D
• Company DUNS: 631064672
• Company Name: GENORAY CO., LTD.
• 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	08809244061189 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150354

FDA Product Code

• OAS: X-Ray, Tomography, Computed, Dental

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: 2023-12-08
• Device Publish Date: 2018-03-08

On-Brand Devices [Genoray]

• 08809244060120: ZEN-2090 Turbo
• 08809244061134: PAPAYA 3D Plus
• 08809244061127: PAPAYA 3D
• 08809244061110: PAPAYA Plus
• 08809244061103: PAPAYA
• 08809244060144: Triana
• 08809244060137: Zenis
• 08809244061097: VOLUX 21C
• 08809244061080: VOLUX 21
• 08809244061066: VOLUX
• 08809244061219: OSCAR 15
• 08809244060069: OSCAR 15i
• 08809244060076: GenX-CR
• 08809244060458: OSCAR 15FD
• 08809244061240: PAPAYA 3D Premium Plus
• 08809244061233: PAPAYA 3D Premium
• 08809244061226: ZEN-PX4
• 08809244061202: PORT-X IV
• 08809244061196: Suni Q-C3D
• 08809244061189: Suni Q3D
• 08809244061172: SUNI Pan Q-C
• 08809244061165: SUNI Pan Q
• 08809244061141: PortView
• 08809244061035: The Multiple Name for PORT-XII is ZEN-PX2.
• 08809244060113: OSCAR Classic
• 08809244060106: OSCAR Prime
• 08809244060083: ZEN-7000
• 08809244060021: ZEN-2090 Pro
• 08809244069055: DVAS-M
• 08809244069048: DVAS-W
• 08809244060281: PAPAYA 3D Premium Plus
• 08809244060250: PAPAYA 3D Premium
• 08809244060465: OSCAR 15
• 08809244060243: PAPAYA 3D Plus
• 08809244060236: PAPAYA 3D
• 08809244060229: PAPAYA Plus
• 08809244060199: PAPAYA
• 08809244060090: ZEN-2090 Turbo
• 08809244065088: HESTIA