FDA 510(k)

3D 광학 일관성 톤옴그래피 (3D OCT-1(형식: 마조로2))

K-번호: K233561 · 2024-04-10

결정일2024-04-10

제품 코드OBO

자문 위원회OP

결정Substantially Equivalent

기기 요약

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is the device name listed in this FDA 510(k) record. The listed applicant is Topcon Corporation. It received FDA 510(k) clearance on 2024-04-10 under 510(k) number K233561. The device is classified under product code OBO. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

자주 묻는 질문

What is the 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is a medical device that received FDA 510(k) clearance on 2024-04-10. The listed applicant is Topcon Corporation. The 510(k) number is K233561.

When did 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) receive FDA 510(k) clearance?

3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) received FDA 510(k) clearance on 2024-04-10, under 510(k) number K233561.

Who is the listed applicant for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2))?

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))?

The FDA product code for 3D Optical Coherence Tomography (3D OCT-1(type: Maestro2)) is OBO.

Topcon Corporation를 신청인으로 등재한 기타 기록

K262637SLIT LAMP SL-D4 (Type: LED)K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA K2410813D 광학 일관성 톤옴그래피 3D OCT-1 (형식: 마조로2); IMAGEnet6 시력 데이터 시스템 K232828IMAGEnet6 Ophthalmic Data System K2312223D 광학 일관성 톤옴그래피 3D OCT-1(형식: 마조로2)K221111Non-Mydriatic Retinal Camera NW500

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