FDA 510(k)

Swoop 便携式磁共振成像（POC MRI）扫描系统

K号: K212456 · 2021-11-17

决定日期2021-11-17

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine, Inc.. It received FDA 510(k) clearance on 2021-11-17 under 510(k) number K212456. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is a medical device that received FDA 510(k) clearance on 2021-11-17. The listed applicant is Hyperfine, Inc.. The 510(k) number is K212456.

When did Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System receive FDA 510(k) clearance?

Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System received FDA 510(k) clearance on 2021-11-17, under 510(k) number K212456.

Who is the listed applicant for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

FDA 510(k)记录中列出Hyperfine, Inc.为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System?

The FDA product code for Swoop Point-of-Care Magnetic Resonance Imaging (POC MRI) Scanner System is LNH.

列明Hyperfine, Inc.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。

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官方来源

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