FDA 510(k)

3D 光相干断层扫描 3D OCT-1 (类型：Maestro2)；IMAGEnet6 眼科数据系统

K号: K241081 · 2024-07-17

决定日期2024-07-17

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); 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.

常见问题

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?

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); IMAGEnet6 Ophthalmic Data System?

The FDA product code for 3D OPTICAL COHERENCE TOMOGRAPHY 3D OCT-1 (type: Maestro2); IMAGEnet6 Ophthalmic Data System 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 K2335613D 光学相干断层扫描 (3D OCT-1(type: Maestro2))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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数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。