3D Accuitomo XYZ Slice View Tomograph

GUDID 04548213025046

J.MORITA MFG.CORP.

Cone beam computed tomography system, head/neck

• Primary Device ID: 04548213025046
• NIH Device Record Key: 9a3bd8b5-b4ae-4af6-8f3f-ad7229be3eb1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: 3D Accuitomo XYZ Slice View Tomograph
• Version Model Number: MCT-1
• Company DUNS: 693811465
• Company Name: J.MORITA MFG.CORP.
• 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: true
• OTC Over-The-Counter: false

Operating and Storage Conditions

• Storage Environment Temperature: Between -5 Degrees Celsius and 43 Degrees Celsius
• Storage Environment Humidity: Between 8 Percent (%) Relative Humidity and 85 Percent (%) Relative Humidity
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Handling Environment Temperature: Between 10 Degrees Celsius and 30 Degrees Celsius
• Handling Environment Humidity: Between 30 Percent (%) Relative Humidity and 75 Percent (%) Relative Humidity
• Handling Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	04548213025046 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K073695

FDA Product Code

• JAK: System, X-Ray, Tomography, Computed

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: 2016-08-27

On-Brand Devices [3D Accuitomo XYZ Slice View Tomograph]

• 04548213025046: MCT-1
• 04548213018611: MCT-1
• 04548213016341: MCT-1