TxStudio

GUDID 00852060007266

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: 00852060007266
• NIH Device Record Key: 21d4d245-00f6-4eb8-bc07-74e4329d9e74
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: TxStudio
• Version Model Number: 7.0
• 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	00852060007266 [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: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2023-11-27
• Device Publish Date: 2023-11-17

On-Brand Devices [TxStudio]

• 00852060007037: 3D imaging application specialized in dental and medical applications such as implantology, orth
• 00852060007266: 3D imaging application specialized in dental and medical applications such as implantology, orth