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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 a medical device manufactured by Pulmonx Corporation. It received FDA 510(k) clearance on 2021-09-02 under approval 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. It is manufactured by Pulmonx Corporation. The 510(k) number is K212494.

When was Lung Image Analysis approved by the FDA?

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

What company makes Lung Image Analysis?

Lung Image Analysis is manufactured by Pulmonx Corporation.

What is the FDA product code for Lung Image Analysis?

The FDA product code for Lung Image Analysis is JAK.

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Related PubMed Literature

PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026) PMID: 40619298 Software-based finger joint range of motion analysis: Current concepts, considerations, and challenges. Journal of hand therapy : official journal of the American Society of Hand Therapists (2025) PMID: 40442400 A scoping review of artificial intelligence as a medical device for ophthalmic image analysis in Europe, Australia and America. NPJ digital medicine (2025)

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Official Source

View on FDA Database →

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

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