HOLOSCOPE

GUDID 07290018862018

REAL VIEW IMAGING LTD

Ultrasound imaging system workstation

• Primary Device ID: 07290018862018
• NIH Device Record Key: a3c3e2c7-8c5a-48a7-8f2c-fc3e27edc58f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: HOLOSCOPE
• Version Model Number: HOLOSCOPE-i
• Company DUNS: 532450660
• Company Name: REAL VIEW IMAGING 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: 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	07290018862018 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K210072

FDA Product Code

• LLZ: System, Image Processing, Radiological

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: 2021-11-09
• Device Publish Date: 2021-11-01