FDA 510(k)

3D 光学相干断层扫描 (3D OCT-1(type: Maestro2))

K号: K233561 · 2024-04-10

决定日期2024-04-10

产品代码OBO

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决定实质等同

器械摘要

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.

常见问题

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))?

FDA 510(k)记录显示Topcon Corporation为申请人。这本身并不能确立该设备制造商的身份。

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.

列明Topcon Corporation为申报人的其他记录

关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。

K262637裂隙灯 SL-D4（类型：LED）K253039AUTO KERATO-REFRACTO TONOMETER TRK-3 OMNIA K2410813D 光相干断层扫描 3D OCT-1 (类型：Maestro2)；IMAGEnet6 眼科数据系统 K232828IMAGEnet6 眼科数据系统 K2312223D 光相干断层扫描 3D OCT-1(type: Maestro2)K221111非散列视网膜相机 NW500

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官方来源

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