RETeval-DR Disp. Sensor Strips 50-Pair

Product Overview

Welch Allyn, Inc. - 901102

Device Description

An electrically-powered optical device intended to be used to create digital colour photographic images/video of the ocular fundus (interior eye surface opposite the lens) through the pupil, to aid in diagnosing and monitoring retinal pathology; it may also be used for images/video of the anterior chamber. The image/video is typically transferred to a computer for display on its screen and/or for storage in a database. This device is also known as a retinal camera.

Environmental Conditions

No Data Available

Device Sizes

No Data Available

Device Sterilization

Device Sterile: True

Sterilization Prior To Use: False

Sterilization Methods: No Data Available

Product Codes

Code: PJZ

Device Name: Camera, Ophthalmic, General-Use

Device Class: 2

Physical State: PJZ cameras are designed for true color or monochrome imaging in visible spectrum of light and consists of an incoherent light source, image forming lens, aperture, and a sensitive photodetector array (e.g., a CCD array) in the image plane. PJZ excludes cameras that make use of advanced imaging technology (e.g., confocal imaging, adaptive optics, two photon imaging, stroboscopic or scanning illumination). PJZ excludes cameras that feature any special imaging modalities, such as multispectral imaging, fluorescence, autofluorescence, fluorescein angiography, indocyanine green (ICG) angiography, etc. PJZ exclude cameras that designed to contact cornea or any other ocular structure for imaging.

Definition: PJZ cameras are prescription devices indicated only for the capture and storage of images of the eye and surrounding area in the general population. PJZ cameras cannot be indicated for any specific population (e.g., pediatrics, AMD patients, etc.), cannot contain any type of “diagnostic” or “aid in diagnosis” claims in the indication for use, and cannot reference any specific disease. PJZ cameras do not exceed group 1 radiant exposure limits for ultraviolet, visible, and infrared radiation under all light energy conditions, as defined in the ANSI Z80.36-2016 standard Light Hazard Protection for Ophthalmic Instruments.

Submission Type ID: 4

Review Panel: OP

Review Code: N/A

Technical Method: N

Gmp Exempt Flag: PJZ cameras meet optical performance characteristics stated in the ISO 10940-2009 standard, Ophthalmic instruments— Fundus cameras. PJZ cameras are limited to basic processing of the displayed image (brightness, contrast, white balance) and does not include any advanced software capabilities (e.g., image feature measurements, cup-to-disc ratio analysis, image feature extractions, segmentation, image registration, analysis of oxygen saturation, blood flow velocity) or reference database. Image storage capability should include read-only raw data format. If compressed images are saved, they must be distinguished from and traceable to the raw source image.

Life Sustain Support Flag: N

Unclassified Reason: N/A

Implant Flag: N

Target Area: The target area is the eye (lid, orbit) and ocular tissues (anterior and posterior segment).

Regulation Number: 886.1120

Third Party Flag: N

Medical Specialty: OP

Device Identifiers

Device Id: 00732094214758

Device Type: Primary

DeviceId Issuing Agency: GS1

Contains DI Number: N/A

Package Quantity: N/A

Package Discontinue Date: N/A

Package Status: N/A

Package Type: N/A

Educational Resources