InvivoMac

GUDID 00852060007044

3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative.

ANATOMAGE, INC.

Radiology information system application software

• Primary Device ID: 00852060007044
• NIH Device Record Key: 3e53f578-fd1a-4e97-8e36-f32819be13ae
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: InvivoMac
• Version Model Number: 6.0
• Company DUNS: 962613332
• Company Name: ANATOMAGE, INC.
• 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: true
• Serial Number: false
• 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

Device Identifiers

Device Issuing Agency	Device ID
GS1	00852060007044 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K123519

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2017-12-07

Devices Manufactured by ANATOMAGE, INC.

• 00852060007266 - TxStudio: 2023-11-27 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest
• 00852060007259 - Table: 2023-10-03 Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, educators, and othe
• 00852060007242 - InvivoDental: 2023-04-24 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest
• 00852060007105 - InVivo Web Viewer: 2019-03-29 InVivo Web Viewer is a software application used for the display and 3D visualization of medical image files from scanning devic
• 00852060007006 - InvivoDental: 2018-07-06 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest
• 00852060007013 - Anatomage Table: 2018-07-06 Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, and other qualified
• 00852060007037 - TxStudio: 2018-07-06 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest
• 00852060007044 - InvivoMac: 2018-07-063D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and restorative.
• 00852060007044 - InvivoMac: 2018-07-06 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest