FDA 510(k)

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); Sistema de Dados Oftalmológicos IMAGEnet6

Número K: K241081 · 2024-07-17

Data da decisão2024-07-17

Código do produtoOBO

Comité consultivoOP

DecisãoSubstantially Equivalent

Resumo do dispositivo

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-07-17 under 510(k) number K241081. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System is a medical device that received FDA 510(k) clearance on 2024-07-17. The listed applicant is Topcon Corporation. The 510(k) number is K241081.

When did 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System receive FDA 510(k) clearance?

3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System received FDA 510(k) clearance on 2024-07-17, under 510(k) number K241081.

Who is the listed applicant for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System?

The FDA 510(k) record lists Topcon Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System?

The FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System is OBO.

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Outros registros que listam Topcon Corporation como candidato(a)

K262637SLIT LAMP SL-D4 (Type: LED)K253039AUTO KERATO-REFRACTO TONÔMETRO TRK-3 OMNIA K2335613D Optical Coherence Tomography (3D OCT-1(type: Maestro2))K232828IMAGEnet6 Ophthalmic Data System K2312223D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1(type: Maestro2)K221111Non-Mydriatic Retinal Camera NW500

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Dispositivos Relacionados (Código: OBO)

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