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FDA 510(k)

ScanDiags Ortho L-Spine MR-Q

K号: K242607 · 2025-02-21

申请人Scandiags AG
决定日期2025-02-21
产品代码QIH
咨询委员会RA
决定实质等同

器械摘要

ScanDiags Ortho L-Spine MR-Q is the device name listed in this FDA 510(k) record. The listed applicant is Scandiags AG. It received FDA 510(k) clearance on 2025-02-21 under 510(k) number K242607. The device is classified under product code QIH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ScanDiags Ortho L-Spine MR-Q?

ScanDiags Ortho L-Spine MR-Q is a medical device that received FDA 510(k) clearance on 2025-02-21. The listed applicant is Scandiags AG. The 510(k) number is K242607.

When did ScanDiags Ortho L-Spine MR-Q receive FDA 510(k) clearance?

ScanDiags Ortho L-Spine MR-Q received FDA 510(k) clearance on 2025-02-21, under 510(k) number K242607.

Who is the listed applicant for ScanDiags Ortho L-Spine MR-Q?

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

What is the FDA product code for ScanDiags Ortho L-Spine MR-Q?

The FDA product code for ScanDiags Ortho L-Spine MR-Q is QIH.

相关临床试验

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。

相关器械(代码:QIH)

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。

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