SICAT Endo 6622463

GUDID D77666224630

Radiological Visualization Software for Diagnosis and Dental Treatment Planning

SiCAT GmbH & Co. KG

Radiology PACS software

• Primary Device ID: D77666224630
• NIH Device Record Key: c4e38782-fbbd-4adb-9a91-2548190695e3
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SICAT Endo
• Version Model Number: 6622463
• Catalog Number: 6622463
• Company DUNS: 333707003
• Company Name: SiCAT GmbH & Co. KG
• 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: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	D77666224630 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K180262

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: 4
• Public Version Date: 2019-05-23
• Device Publish Date: 2018-04-09

On-Brand Devices [SICAT Endo]

• D776ENDOV20: V2.0
• D776ENDOV200: V2.0
• D77666224630: Radiological Visualization Software for Diagnosis and Dental Treatment Planning
• D776ENDOV20400: V2.0.40