Identity
- Trade Name
- PanoCam™ SOLO FDA UDI
- Generic Name
- External ocular measurement camera FDA UDI
- Device Name
- 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. FDA UDI
- Model / Reference
- PanoCam™ SOLO FDA UDI
- 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. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00850938007042 FDA UDI
- FDA Product Code
- PJZ FDA UDI
- GMDN Term
- External ocular measurement camera FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.1120 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: External ocular measurement camera
PanoCam™ SOLO by Visunex Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Visunex Medical Systems Inc.
Sources (1)
- FDA UDI d77312d6-4dbe-4980-a3a4-504210fa2645 35 fields · synced May 31, 2026