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…
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.
Who Else Makes It
Concentrated in Chongqing (5), Jiangsu (3), Zhejiang (2).
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| PNPR-11-10-11 | In distribution | |
| PNPR-11-10-23 | In distribution |
Same 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.