PanoCam™ LT

Primary DI
00850938007004
Brand
PanoCam™ LT
Company
VISUNEX MEDICAL SYSTEMS INC.
Model
PNLT-10-10-11
Device description
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.
Published
2016-09-24
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
PJZCamera, Ophthalmic, General-Use

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
PJZCamera, Ophthalmic, General-UseOphthalmic2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850938007004PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850938007004008509380070048509380070040850938007004

GMDN Terms#

Term, Definition table
TermDefinition
External ocular measurement cameraA hand-held, battery-powered, optical device intended for digital image capture and analysis of the external ocular anatomy to assist in the diagnosis of ophthalmic abnormalities (e.g., ptosis, strabismus, glaucoma); it is not intended to capture images of the fundus. It consists of a digital camera which includes software intended to take specific ocular measurements (e.g., pupil diameter, horizontal visible iris diameter, margin reflex difference, interpupillary distance, strabismus angle).

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Storage Environment Atmospheric Pressure70 KiloPascal106 KiloPascal
Storage Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-10 Degrees Celsius55 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
844-273-1580info@visunexmedical.com

Regulatory Flags#

DUNS number
080033068
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850938007011PanoCam™ PRO PNPR-11-10-112016-09-24
00850938007028PanoCam™ PROPNPR-11-10-232017-08-31
00850938007035PanoCam™ LTPNLT-10-10-232017-08-31
00850938007042PanoCam™ SOLOPanoCam™ SOLO2018-02-01

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