Vitrea Software Toshiba Package

GUDID 04987670102493

This device was previously sold by TOSHIBA MEDICAL SYSTEMS CORPORATION under the brand name Vitrea Software Toshiba Package. Effective Jan 2018, the company name changed to CANON MEDICAL SYSTEMS CORPORATION. The device brand name is now Vitrea Software Package.

CANON MEDICAL SYSTEMS CORPORATION

Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software Radiology DICOM image processing application software

• Primary Device ID: 04987670102493
• NIH Device Record Key: 5fe1b51f-cb4b-41df-8cd7-d8d3afc2e4ce
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Vitrea Software Toshiba Package
• Version Model Number: VSTP-001A
• Company DUNS: 690575113
• Company Name: CANON MEDICAL SYSTEMS CORPORATION
• 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: 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

Customer Support Contacts

• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx
• Phone: +1-8004211968
• Email: xxx@xxx.xxx

Device Identifiers

Device Issuing Agency	Device ID
GS1	04987670102493 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K151091

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: 2019-10-07
• Device Publish Date: 2018-03-02

Devices Manufactured by CANON MEDICAL SYSTEMS CORPORATION

• 04987670100925 - BIOPSY ADAPTOR: 2024-04-22
• 04987670104626 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104633 - LINEAR ARRAY TRANSDUCER: 2024-04-22
• 04987670104640 - ENDOCAVITARY TRANSDUCER: 2024-04-22
• 04987670104664 - CONVEX ARRAY TRANSDUCER: 2024-04-22
• 04987670106033 - CONVEX ARRAY TRANSDUCER: 2024-04-22
• 04987670106057 - CONVEX ARRAY TRANSDUCER: 2024-04-22
• 04987670100680 - BIOPSY ADAPTOR: 2024-04-16