PanoCam™ LT

GUDID 00850938007004

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.

VISUNEX MEDICAL SYSTEMS INC.

External ocular measurement camera

• Primary Device ID: 00850938007004
• NIH Device Record Key: da957c01-ac87-4021-a824-115b225eecc1
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: PanoCam™ LT
• Version Model Number: PNLT-10-10-11
• Company DUNS: 080033068
• Company Name: VISUNEX MEDICAL SYSTEMS INC.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: false
• Serial Number: true
• Manufacturing Date: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Customer Support Contacts

• Phone: 844-273-1580
• Email: info@visunexmedical.com

Operating and Storage Conditions

• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal
• Storage Environment Atmospheric Pressure: Between 70 KiloPascal and 106 KiloPascal

Device Identifiers

Device Issuing Agency	Device ID
GS1	00850938007004 [Primary]

FDA Product Code

• PJZ: Camera, Ophthalmic, General-Use

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: Update
• Device Record Status: Published
• Public Version Number: 3
• Public Version Date: 2018-10-09
• Device Publish Date: 2016-09-24

On-Brand Devices [PanoCam™ LT]

• 00850938007035: PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and prop
• 00850938007004: PanoCam™ LT Wide-field Digital Imaging System is developed using the state-of-the art and prop