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PanoCam™ PRO

FDA UDI

Class II (US FDA UDI)

by Visunex Medical Systems Inc.

Identity

Trade Name
PanoCam™ PRO FDA UDI
Generic Name
External ocular measurement camera FDA UDI
Device Name
PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection. FDA UDI
Model / Reference
PNPR-11-10-23 FDA UDI
Description
PanoCam™ PRO Ophthalmic Digital Imaging System is developed using the state-of-the art and proprietary technologies for imaging the fundus, cornea and exterior of the eyes. The system consists of the standard lens and the optional high magnification lens which capture True-color™ high-resolution images of the eyes regardless of the retinal pigment color and with a field of view of up to 130 degrees and approximately 80 degrees, respectively. PanoCam™ PRO is a fully integrated system consisting of the wireless IRIS™ (Independent Remote Imaging Station) and the Imaging System Console on a cart. It is highly mobile, as the cart can be easily move around within hospital facilities and the untethered and light weight IRIS™ hand piece allows convenient image capture in multiple locations away from the console. The software is DICOM compliant, allowing data and images to be transferred easily and securely using wireless connections. PanoCam™ PRO is user friendly and can be operated by a single individual with proper training. The system is ideally suited as a diagnostic and observation instrument for ophthalmologists in clinics and surgical rooms. It can be used for general ophthalmic imaging and eye disease inspection. FDA UDI

Identifiers

Primary DI / UDI-DI
00850938007028 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™ PRO by Visunex Medical Systems Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as External ocular measurement camera.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Visunex Medical Systems Inc.

Sources (1)

  • FDA UDI 122882bd-723b-44d0-82c1-b807a026b042 35 fields · synced May 30, 2026