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…

Registry build 21.09.26

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.

14manufacturers in China registered for this device type
2catalogue numbers in this listing

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™ PRO
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 2016-09-24
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 humidity 10 to 95 % RH; Storage environment atmospheric pressure 70 to 106 KiloPascal

Catalogue Numbers

Catalogue numbers for PanoCam™ PRO
Catalogue number Size Status
PNPR-11-10-11 In distribution
PNPR-11-10-23 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