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FDA 510(k)

Lung Image Analysis

K-Number: K212494 · 2021-09-02

ApplicantPulmonx Corporation
Decision Date2021-09-02
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Lung Image Analysis is the device name listed in this FDA 510(k) record. The listed applicant is Pulmonx Corporation. It received FDA 510(k) clearance on 2021-09-02 under 510(k) number K212494. The device is classified under product code JAK. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Lung Image Analysis?

Lung Image Analysis is a medical device that received FDA 510(k) clearance on 2021-09-02. The listed applicant is Pulmonx Corporation. The 510(k) number is K212494.

When did Lung Image Analysis receive FDA 510(k) clearance?

Lung Image Analysis received FDA 510(k) clearance on 2021-09-02, under 510(k) number K212494.

Who is the listed applicant for Lung Image Analysis?

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

What is the FDA product code for Lung Image Analysis?

The FDA product code for Lung Image Analysis is JAK.

Other records listing Pulmonx Corporation 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.

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Related Devices (Code: JAK)

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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.

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