Genoray

GUDID 08809244061127

Genoray Co., Ltd.

Stationary panoramic/tomographic dental x-ray system, digital

• Primary Device ID: 08809244061127
• NIH Device Record Key: 714a5504-d147-4754-9284-9d5fefa90294
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Genoray
• Version Model Number: PAPAYA 3D
• 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	08809244061127 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K150354

FDA Product Code

• MUH: System,X-Ray,Extraoral Source,Digital

Sterilization

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

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 4
• Public Version Date: 2022-05-27
• Device Publish Date: 2016-12-28

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