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™…

Registry build 21.09.26

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.

14manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Chongqing (5), Jiangsu (3), Zhejiang (2).

Chinese manufacturers registered for FDA product code PJZ
Manufacturer City Province Registered as Device types
Beijing Hongdee Corporation Beijing Beijing Private-label distributor 43
Taizhou City K&W International Trade Co., Ltd. Jiangyan Jiangsu Repacker / relabeller 38
Shanghai Link Instruments Co., Ltd. Changzhou Jiangsu Manufacturer 21
Shanghai Mediworks Precision Instruments Co., Ltd. Shanghai Shanghai Contract manufacturer 13
Chongqing Sunkingdom Medical Instrument Co., Ltd. Chongqing Chongqing Manufacturer 11
Ningbo Ming Sing Optical R&D Co., Ltd. Ningbo Zhejiang Repacker / relabeller 9
Shenzhen Create Technology Co., Ltd. Shenzhen Guangdong Manufacturer 9
Visuscience Meditech Co., Ltd. Wuxi Jiangsu Specification developer 9
Main Meditech Co., Ltd. Chongqing Chongqing Contract manufacturer 5
Chongqing Kanghua Ruiming S&T Co., Ltd. Chongqing Chongqing Contract manufacturer 3
Chongqing SS Medical Equipments Co., Ltd. Chongqing Chongqing Manufacturer 3
Chongqing BIO Newvision Medical Equipment Ltd. Chongqing Chongqing Manufacturer 2

Showing 12 of 14. All 14 manufacturers in China registered for Camera, Ophthalmic, General-Use

Record

Regulatory record for PanoCam™ Solo
Listed by Visunex Medical Systems Inc.
FDA product code PJZ
Device type Camera, Ophthalmic, General-Use
Device class Class 2
Regulation 21 CFR 886.1120
Premarket notification Exempt
Record published 2018-02-01
Record revised 2018-10-09 (version 3)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Label carries manufacturing date, serial number
Storage Storage environment temperature -10 to 55 °C; Storage environment atmospheric pressure 70 to 106 KiloPascal; Storage environment humidity 10 to 95 % RH

Catalogue Numbers

Catalogue numbers for PanoCam™ Solo
Catalogue number Size Status
PanoCam™ SOLO In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Welch Allyn, Inc. Welch Allyn, Inc. 12
3nethra Forus Health Pvt.ltd., 12
Welch Allyn Medimaging Integrated Solution Inc. 6
Fundus Camera Chongqing Sunkingdom Medical Instrument Co., Ltd. 6
D-EYE D-EYE SRL 4
Microclear Suzhou Microclear Medical Instruments Co., Ltd. 4
Mediworks Shanghai Mediworks Precision Instruments Co., Ltd. 3
EyeCaster Innovations Lightx Inc 3
Paxos Scope Digisight Technologies, Inc. 3
Remidio Remidio Innovative Solutions Inc 3
Volk Viva Volk Optical Inc. 2
Volk VistaView Volk Optical Inc. 2

Showing 12 of 48. All products under Camera, Ophthalmic, General-Use

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer