HOLOSCOPE

Basic Information

• Brand Name: HOLOSCOPE
• Primary DI: 07290018862018
• Version / Model: HOLOSCOPE-i
• Company Name: REAL VIEW IMAGING LTD
• Labeler DUNS: 532450660
• Distribution Status: In Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2021-11-01
• Public Version: 1
• Public Version Date: 2021-11-09
• Public Version Status: New
• Public Device Record Key: a3c3e2c7-8c5a-48a7-8f2c-fc3e27edc58f

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: Yes
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
LLZ	System, Image Processing, Radiological	Radiology	892.2050	2

GMDN Terms

Code	Name	Definition	Implantable	Status
40936	Ultrasound imaging system workstation	A freestanding image processing workstation specifically designed to be networked with one or more diagnostic ultrasound imaging systems. It is sometimes considered to be a component to a picture archiving and communication system (PACS). An ultrasound workstation differs from the operator's console in that it does not contain the controls for the direct operation of the diagnostic imaging system. It is designed to receive and transmit data both on-line and off-line and is typically located at a site remote from the operator console. It has the capability to further process, manipulate and/or view patient images and information collected from one or more ultrasounds.	No	Active
36572	CT system workstation	A device that is a component of a computed tomography (CT) system and which is designed to receive and transmit data both on-line and off-line. It is typically located at a site remote from the operator's console. It differs from the operator console in that it does not contain the controls for the direct operation of the CT system. It is configured to provide the capability to further process, manipulate and/or view patient images and information collected from the CT system and possibly other related x-ray based imaging systems.	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	07290018862018	GS1

Premarket Submissions

Submission Number	Supplement Number
K210072	000