Table

GUDID 00852060007259

Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, educators, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes.

ANATOMAGE, INC.

Radiology information system application software

• Primary Device ID: 00852060007259
• NIH Device Record Key: 1ed828fb-8384-49fa-927c-3cf37742ab31
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Table
• Version Model Number: 9.0
• 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: 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	00852060007259 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K140093

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2023-10-03
• Device Publish Date: 2023-09-25

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: 2023-10-03Anatomage Table is a volumetric imaging software designed specifically for clinicians, doctors, physicians, educators, and other qualified medical professionals. The software runs in Windows operating systems and visualizes medical imaging data on the computer screen. Users are able to examine anatomy on a computer screen and use software tools to move and manipulate images by turning, zooming, flipping, adjusting contrast and brightness, cutting, and slicing using either touch control or a mouse. The software also has the ability to perform measurements of angle and length. There are multiple tools to annotate and otherwise mark areas of interest on the images. Additionally, Table has the ability to demonstrate pathology examples of patient data for educational purposes.
• 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: 2018-07-06 3D imaging application specialized in dental and medical applications such as implantology, orthodontics, oral surgery, and rest