HealthPPT

GUDID 07290018016107

ZEBRA MEDICAL VISION LTD

Radiology DICOM image processing application software

• Primary Device ID: 07290018016107
• NIH Device Record Key: 89840c32-2fdb-4449-9803-6d37f51cb929
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HealthPPT
• Version Model Number: 1.0
• 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: 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	07290018016107 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K211803

FDA Product Code

• QFM: Radiological Computer-Assisted Prioritization Software For Lesions

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: 2022-01-07
• Device Publish Date: 2021-12-30

Devices Manufactured by ZEBRA MEDICAL VISION LTD

• 07290018016107 - HealthPPT: 2022-01-07
• 07290018016107 - HealthPPT: 2022-01-07
• 07290018016091 - HealthCCSng: 2021-10-26
• 07290018016060 - HealthMammo: 2020-09-29
• 07290018016084 - HealthVCF: 2020-09-29
• 07290018016053 - HealthICH: 2020-03-16
• 07290018016046 - HealthCXR: 2020-01-13
• 07290018016039 - HealthICH: 2020-01-09
• 07290018016022 - HealthICH: 2019-10-07