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FDA 510(k)

XV Lung Ventilation Analysis Software

K-Number: K193293 · 2020-05-14

Applicant4Dx Limited
Decision Date2020-05-14
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

XV Lung Ventilation Analysis Software is the device name listed in this FDA 510(k) record. The listed applicant is 4Dx Limited. It received FDA 510(k) clearance on 2020-05-14 under 510(k) number K193293. 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 XV Lung Ventilation Analysis Software?

XV Lung Ventilation Analysis Software is a medical device that received FDA 510(k) clearance on 2020-05-14. The listed applicant is 4Dx Limited. The 510(k) number is K193293.

When did XV Lung Ventilation Analysis Software receive FDA 510(k) clearance?

XV Lung Ventilation Analysis Software received FDA 510(k) clearance on 2020-05-14, under 510(k) number K193293.

Who is the listed applicant for XV Lung Ventilation Analysis Software?

The FDA 510(k) record lists 4Dx Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for XV Lung Ventilation Analysis Software?

The FDA product code for XV Lung Ventilation Analysis Software is JAK.

Related Clinical Trials

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.

NCT07644104Efficacy and Safety of the Visual Bronchial Blocker for Lung Isolation SurgeryNOT_YET_RECRUITINGNCT07585019Ventilator Study in the NICUNOT_YET_RECRUITING

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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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