PanoCam™ LT - PanoCam™ LT Wide-field Digital Imaging System is - VISUNEX MEDICAL SYSTEMS INC.

Duns Number:080033068

Device Description: PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. It provides True-color™ high-resolution images of the eyes of the patients regardless of the retinal pigment color and with a field of view of up to 130 degrees. PanoCam™ LT is a fully integrated system consisting of the Image Capturing Unit™, Computer Console, and Integrated Color Printer. It is highly mobile, allowing convenient image capture by the untethered Image Capturing Unit™ hand piece in multiple hospital rooms and exam lanes. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ LT is ideally suited as a mobile device for general ophthalmic imaging and eye disease inspection.

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More Product Details

Catalog Number

-

Brand Name

PanoCam™ LT

Version/Model Number

PNLT-10-10-23

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

Product Characteristics

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)

-

Device labeled as "Not made with natural rubber latex"

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For Single-Use

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Prescription Use (Rx)

-

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

-

Product Code Details

Product Code

PJZ

Product Code Name

Camera, Ophthalmic, General-Use

Device Record Status

Public Device Record Key

052e06a4-8a7a-473c-9abf-e67c872fee98

Public Version Date

October 09, 2018

Public Version Number

3

DI Record Publish Date

August 31, 2017

Additional Identifiers

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-

"VISUNEX MEDICAL SYSTEMS INC." Characteristics
Device Class Device Class Description No of Devices
2 A medical device with a moderate to high risk that requires special controls. 5