FDA 510(k)

Lucy 便携式磁共振成像设备

K号: K192002 · 2020-02-06

决定日期2020-02-06

产品代码LNH

咨询委员会RA

决定实质等同

器械摘要

Lucy Point-of-Care Magnetic Resonance Imaging Device is the device name listed in this FDA 510(k) record. The listed applicant is Hyperfine Research, Inc.. It received FDA 510(k) clearance on 2020-02-06 under 510(k) number K192002. 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 Lucy Point-of-Care Magnetic Resonance Imaging Device?

Lucy Point-of-Care Magnetic Resonance Imaging Device is a medical device that received FDA 510(k) clearance on 2020-02-06. The listed applicant is Hyperfine Research, Inc.. The 510(k) number is K192002.

When did Lucy Point-of-Care Magnetic Resonance Imaging Device receive FDA 510(k) clearance?

Lucy Point-of-Care Magnetic Resonance Imaging Device received FDA 510(k) clearance on 2020-02-06, under 510(k) number K192002.

Who is the listed applicant for Lucy Point-of-Care Magnetic Resonance Imaging Device?

The FDA 510(k) record lists Hyperfine Research, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Lucy Point-of-Care Magnetic Resonance Imaging Device?

The FDA product code for Lucy Point-of-Care Magnetic Resonance Imaging Device is LNH.

列明Hyperfine Research, 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。

K202414BrainInsight K201722超精细便携式磁共振成像（POC MRI）扫描系统

官方来源

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