OPTICAL COHERENCE TOMOGRAPHY

Basic Information

• Brand Name: OPTICAL COHERENCE TOMOGRAPHY
• Primary DI: 04987669100516
• Version / Model: RS-3000 Advance
• Company Name: NIDEK CO.,LTD.
• Labeler DUNS: 690635461
• Distribution Status: Not in Commercial Distribution
• Device Count in Pkg: 1
• Record Status: Published
• Publish Date: 2016-06-24
• Public Version: 3
• Public Version Date: 2026-04-10
• Public Version Status: Update
• Public Device Record Key: 05425139-b4c7-436b-8370-5d720a8aa846
• Distribution End Date: 2025-12-22

Device Description

The NIDEK Optical Coherence Tomography RS-3000 Advance is an ophthalmic camera that allows non-invasive and non-contact observation of the shape of the fundus or retina. Fundus surface images (hereafter referred to as SLO image) are captured with the confocal laser scanning using a near-infrared light source with a wavelength of 785 nm. Cross-sectional images of the retina (hereafter referred to as OCT image) are captured with the optical interferometer using an infrared light source with a wavelength of 880 nm. With the images captured using the RS-3000 Advance, the shape and structure of the fundus or retina can be observed, and diseases can be observed. This system is comprised of the main body for capturing images, a computer (hereafter called PC) for storing and analyzing captured images, PC monitor, and an isolation transformer. In addition, the image filing software NAVIS-EX (hereafter referred to as NAVIS-EX) offers the following features: • Image analysis functions such as 3D/map color display or retinal thickness analysis • Networking for data review or analysis on PCs in separate locations

Device Characteristics

• Single Use: No
• Prescription Use (Rx): Yes
• Over the Counter (OTC): No
• Kit: No
• Combination Product: No
• HCT/P: No
• Contains NRL: No
• Not Made with NRL: No
• MRI Safety: Labeling does not contain MRI Safety Information
• Direct Marking Exempt: No
• PM Exempt: No
• Has Serial Number: Yes
• Has Lot/Batch Number: No
• Has Manufacturing Date: No
• Has Expiration Date: No
• Has Donation ID: No

Sterilization

• Is Sterile: No
• Sterilization Prior Use: No

Product Codes

Code	Name	Medical Specialty	Regulation #	Device Class
OBO	Tomography, Optical Coherence	Ophthalmic	886.1570	2

GMDN Terms

Code	Name	Definition	Implantable	Status
64004	Scanning-laser ophthalmoscope/retinal optical coherence tomography system	An ophthalmic digital image capturing/processing device that is a combination of a scanning-laser ophthalmic imaging system and a retinal optical coherence tomography system intended to: 1) use a low power laser to generate and capture digital confocal images, 2) use a broad-bandwidth light beam aimed into the eye for in vivo tomographic imaging and measurement, of the retina and associated structures to diagnose and manage retinal diseases. It typically consists of a laser, optics, image detection system, a digital processor/computer, application software and image display monitor(s).	No	Active

Identifiers

Type	ID	Issuing Agency	Package Type	Qty per Pkg	Pkg Status	Pkg Discontinue Date
Primary	04987669100516	GS1

Customer Contacts

• Phone: [phone]
• Email: [email protected]