Duns Number:080033068
Device Description: PanoCam™ SOLO Ophthalmic Imaging System is intended for general ophthalmic imaging and dis 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.
Catalog Number
-
Brand Name
PanoCam™ SOLO
Version/Model Number
PanoCam™ SOLO
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
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Device labeled as "Not made with natural rubber latex"
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For Single-Use
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Prescription Use (Rx)
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Over the Counter (OTC)
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Kit
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Combination Product
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Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
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FDA Premarket Submission
-
Product Code
PJZ
Product Code Name
Camera, Ophthalmic, General-Use
Public Device Record Key
d77312d6-4dbe-4980-a3a4-504210fa2645
Public Version Date
October 09, 2018
Public Version Number
3
DI Record Publish Date
February 01, 2018
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 2 | A medical device with a moderate to high risk that requires special controls. | 5 |