SafeCT

GUDID 07290016836004

The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT i

MEDIC VISION - IMAGING SOLUTIONS LTD

CT system application software

• Primary Device ID: 07290016836004
• NIH Device Record Key: b0789ddc-854b-4c7a-b6bf-5a5920696e6d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: SafeCT
• Version Model Number: 1.2
• Company DUNS: 514775571
• Company Name: MEDIC VISION - IMAGING SOLUTIONS LTD
• 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: true
• 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

Customer Support Contacts

• Phone: 18002788710
• Email: Support@medicvision.com

Device Identifiers

Device Issuing Agency	Device ID
GS1	07290016836004 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K100372

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: 2018-02-01

Devices Manufactured by MEDIC VISION - IMAGING SOLUTIONS LTD

• 07290016836004 - SafeCT: 2018-07-06The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, processes and transfers CT i
• 07290016836004 - SafeCT: 2018-07-06 The SafeCT is a software package of a PACS server, which is connected to the clinics' Local Area Network (LAN), receives, proces
• 07290016836202 - SafeCT-29: 2018-07-06 Medic Vision’s SafeCT-29 provides a vendor-neutral Radiation Dose Check functionality, in accordance with the Dose Check featu