See Factor CT3

GUDID 00860012510900

Mobile multimodality cone beam computed tomography scanner.

EPICA HUMAN HEALTH LLC

Cone beam computed tomography system, head/neck

• Primary Device ID: 00860012510900
• NIH Device Record Key: e01542b4-062b-4b0c-9042-6cb1abc19831
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: See Factor CT3
• Version Model Number: 9801101000
• Company DUNS: 093459276
• Company Name: EPICA HUMAN HEALTH LLC
• 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: true
• 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
GS1	00860012510900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K233230

FDA Product Code

• OWB: Interventional Fluoroscopic X-Ray System

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: 2024-09-17
• Device Publish Date: 2024-09-09