AccessGUDID - DEVICE: PanoCam™ SOLO (00850938007042)

GUDID

Device Identifier (DI) Information

Brand Name: PanoCam™ SOLO
Version or Model: PanoCam™ SOLO
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: VISUNEX MEDICAL SYSTEMS INC.

Primary DI Number: 00850938007042
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 080033068 *Terms of Use

Device Description: PanoCam™ SOLO Ophthalmic Imaging System is intended for general ophthalmic imaging and disease inspection. It utilizes the super-resolution imaging technology and provides True-color™ high-resolution images of the fundus, cornea and exterior of the eyes with a field of view of up to130 degrees. The SOLO system consists of the wireless Independent Remote Imaging Station (IRIS™), the workstation and the optional wireless footswitch. The IRIS™ is the handheld imaging unit with user interfaces which allow operators to login, edit patient information, control the image capture process, preview and review the captured images. With its own battery, it is light-weight and compact, highly portable and easy to use. It allows operators to image patients at multiple locations within health care facilities. The workstation includes a computer with removable storage media and database, HDMI, USB and network ports, and optional large screen monitor/keyboard/mouse, as well as a built-in battery recharging station. It allows users to recharge the IRIS™ hand piece, review acquired images, edit patient information, generate reports, and print the images with an external printer. The footswitch provides an alternative means for controlling image acquisition. The software for the SOLO system is DICOM compliant, allowing data and images to be transferred easily and securely via internet.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
61569	External ocular measurement camera	A hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle).	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
PJZ	Camera, Ophthalmic, General-Use

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
Premarket Submission Number Not Available/Not Released

Device Exempt from Premarket Submission: Yes CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
Storage Environment Temperature: between -10 and 55 Degrees Celsius
Storage Environment Atmospheric Pressure: between 70 and 106 KiloPascal
Storage Environment Humidity: between 10 and 95 Percent (%) Relative Humidity

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: d77312d6-4dbe-4980-a3a4-504210fa2645
Public Version Date: October 09, 2018
Public Version Number: 3
DI Record Publish Date: February 01, 2018