FDA 510(k)

Novo

K-Number: K212361 · 2022-08-11

Decision Date2022-08-11

Product CodeQKQ

Advisory CommitteePA

DecisionSubstantially Equivalent

Device Summary

Novo is the device name listed in this FDA 510(k) record. The listed applicant is PathAI, Inc.. It received FDA 510(k) clearance on 2022-08-11 under 510(k) number K212361. The device is classified under product code QKQ. It was reviewed by the PA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Novo?

Novo is a medical device that received FDA 510(k) clearance on 2022-08-11. The listed applicant is PathAI, Inc.. The 510(k) number is K212361.

When did Novo receive FDA 510(k) clearance?

Novo received FDA 510(k) clearance on 2022-08-11, under 510(k) number K212361.

Who is the listed applicant for Novo?

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

What is the FDA product code for Novo?

The FDA product code for Novo is QKQ.

Other records listing PathAI, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K243391AISight Dx

Related Devices (Code: QKQ)

K253561Aperio iQC DX SoftwareLeica Biosystems Imaging, Inc.K261380Concentriq AP-DxProscia, Inc.K243449INFINITT DPSInfinitt Healthcare Co., Ltd.K252762HALO AP DxIndica Labs, LLC K243391AISight DxPathAI, Inc.K250968PathPresenter Clinical ViewerPathpresenter Corporation

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.