HealthICH

GUDID 07290018016039

ZEBRA MEDICAL VISION LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018016039
• NIH Device Record Key: 752b2928-b73e-4ba0-b903-6f1d0d277a89
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthICH
• Version Model Number: 2.1.3
• Company DUNS: 600098228
• Company Name: ZEBRA MEDICAL VISION 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: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• 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
GS1	07290018016039 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K190424

FDA Product Code

• QAS: Radiological Computer-Assisted Triage And Notification Software

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: 2020-01-09
• Device Publish Date: 2020-01-01

On-Brand Devices [HealthICH]

• 07290018016022: 2.0.5
• 07290018016039: 2.1.3
• 07290018016053: 3.0.0