Panoura X-ERA

GUDID 04547497759470

Diagnostic imaging equipment for dental treatment. Panoramic, Cephalometric imaging(2 sensors type) & three-dimensional(3D, FOV size x 4) image.

YOSHIDA DENTAL MFG. CO., LTD., THE

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• Primary Device ID: 04547497759470
• NIH Device Record Key: 345ee91e-c072-4d43-8201-8e1452ff1281
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Panoura X-ERA
• Version Model Number: Panoura X-ERA MF C Type 2
• Company DUNS: 690676978
• Company Name: YOSHIDA DENTAL MFG. CO., LTD., THE
• 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: false
• 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

Customer Support Contacts

• Phone: +81336312165
• Email: international-div@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp
• Phone: +81336312165
• Email: yoshida4export-kokusai@yoshida-net.co.jp

Operating and Storage Conditions

• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal
• Storage Environment Atmospheric Pressure: Between -10 Degrees Celsius and 60 Degrees Celsius
• Storage Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.06 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 40 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 0.7 KiloPascal and 1.6 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04547497759470 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K182198

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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2019-05-20
• Device Publish Date: 2019-05-10

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• 04547497759456: Diagnostic imaging equipment for dental treatment. Panoramic imaging & three-dimensional(3D, FOV