VISUNEX MEDICAL SYSTEMS INC.

FDA Registration(s)#

Registration, FEI, Name table
Registration	FEI	Name	Status	Initial importer	Expiration year	Address
3011833592	3011833592	VISUNEX MEDICAL SYSTEMS INC.	1	N	2020-04-25	7100 Stevenson Blvd, Suite 409 Fremont CA US 94538
3011896365	3011896365	VISUNEX MEDICAL SYSTEMS (Suzhou) Co. Ltd.	1	N	2020-04-25	6F, B5 Building, 218 Xinghu Street Suzhou Industrial Park Suzhou Jiangsu CN 215123

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDID	Product	Phone	Email
00850938007004	PanoCam™ LT - PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.	844-273-1580	info@visunexmedical.com
00850938007011	PanoCam™ PRO - PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.	1-844-273-1580	info@visunexmedical.com
00850938007028	PanoCam™ PRO - PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.	1-844-273-1580	info@visunexmedical.com
00850938007035	PanoCam™ LT - PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.	844-273-1580	info@visunexmedical.com
00850938007042	PanoCam™ SOLO - 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.	510.248.4216	info@visunexusa.com
00850938007042	PanoCam™ SOLO - 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.	1-844-273-1580	info@visunexusa.com

Registered Device Listings#

Registration key, Listing key table
Registration key	Listing key
187415	1274352140
192049	1274352140
187415	1805398917
192049	1805398917

GUDID#

PanoCam™ LT - PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
2016-09-24
PanoCam™ PRO - PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
2016-09-24
PanoCam™ PRO - PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
2017-08-31
PanoCam™ LT - PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.
VISUNEX MEDICAL SYSTEMS INC.
2017-08-31
PanoCam™ SOLO - 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.
VISUNEX MEDICAL SYSTEMS INC.
2018-02-01