Optical Coherence Tomography RS-3000 Advance

EUDAMEDFDA UDIFDA 510(k)

Class IIa (EU MDR)

Ref 10703-0050, 10703-02B0Model RS-1,Mirante,RS-3000 Advance510(k) K132323

by NIDEK.CO.Ltd.,

Identity

Trade Name: Optical Coherence Tomography RS-3000 Advance EUDAMED
OPTICAL COHERENCE TOMOGRAPHY FDA UDI
Generic Name: Direct ophthalmoscope, line-powered FDA UDI
Device Name: 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 FDA UDI
Model / Reference: RS-1,Mirante,RS-3000 Advance EUDAMED
10703-0050, 10703-02B0 EUDAMED
RS-3000 Advance FDA UDI
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 FDA UDI

Identifiers

Primary DI / UDI-DI: 04987669100516 EUDAMEDFDA UDI
Basic UDI-DI: 4987669216GF EUDAMED
FDA Product Code: OBO FDA UDI
EMDN Code: Z12120121,Z12120199 EUDAMED
GMDN Term: Direct ophthalmoscope, line-powered FDA UDI

Classification

Device Class: Class IIa EUDAMED
Class II FDA UDI
Regulation Number: 886.1570 FDA UDI
Market of Registration: Germany EUDAMED
Commercial Distribution: In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

EUDAMEDFDA UDI

Single Use

FDA UDI

Implantable

EUDAMEDFDA UDI

Reusable

EUDAMED

Contains Latex

EUDAMEDFDA UDI

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

EUDAMED

Incorporates Medicinal Product

EUDAMED

Prescription Use

Yes

FDA UDI

Over-the-Counter

FDA UDI

Convenience Kit

FDA UDI

Combination Product

FDA UDI

HCT/P

FDA UDI

Premarket Exempt

FDA UDI

Lot / Batch Number

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

FDA UDI

Manufacturing Date

FDA UDI

Optical Coherence Tomography RS-3000 Advance by Nidek Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA GUDID, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K121622	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K132323	Class IIa	Active
EUDAMED	European Union	CE/MDR	4987669216GF	Class IIa	Active

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Manufacturer

Manufacturer: NIDEK.CO.Ltd.,
EUDAMED SRN: JP-MF-000040151
FDA Applicant: Nidek Co., Ltd.
Authorised Representative: NIDEK SA FR-AR-000000341

Sources (4)

EUDAMED 7ec822e7-3c5c-4ac5-ab61-516f67288fb1 85 fields · synced Jul 11, 2026
FDA UDI 05425139-b4c7-436b-8370-5d720a8aa846 34 fields · synced May 30, 2026
EUDAMED 7ec822e7-3c5c-4ac5-ab61-516f67288fb1-1 61 fields · synced Jun 10, 2026
FDA 510(k) K121622 1 fields · synced May 18, 2026