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FDA 510(k)

CT Lung Ventilation Analysis Software (CT:V)

K-Number: K232392 · 2023-11-16

Applicant4Dmedical Limited
Decision Date2023-11-16
Product CodeJAK
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CT Lung Ventilation Analysis Software (CT:V) is the device name listed in this FDA 510(k) record. The listed applicant is 4Dmedical Limited. It received FDA 510(k) clearance on 2023-11-16 under 510(k) number K232392. 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 CT Lung Ventilation Analysis Software (CT:V)?

CT Lung Ventilation Analysis Software (CT:V) is a medical device that received FDA 510(k) clearance on 2023-11-16. The listed applicant is 4Dmedical Limited. The 510(k) number is K232392.

When did CT Lung Ventilation Analysis Software (CT:V) receive FDA 510(k) clearance?

CT Lung Ventilation Analysis Software (CT:V) received FDA 510(k) clearance on 2023-11-16, under 510(k) number K232392.

Who is the listed applicant for CT Lung Ventilation Analysis Software (CT:V)?

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

What is the FDA product code for CT Lung Ventilation Analysis Software (CT:V)?

The FDA product code for CT Lung Ventilation Analysis Software (CT:V) 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

Other records listing 4Dmedical Limited 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.

K251484CT:VQ

Related Devices (Code: JAK)

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.

K253450BodyTom Elite (NL4000)NeuroLogica Corp., a Samsung CompanyK253770CardIQ SuiteGE Medical Systems SCSK253560Enhanced Boundary for PCCTGe Medical Systems, LLCK253026Respiratory Gating for Scanners (2.1)Varian Medical Systems, Inc.K253596Aquilion ONE (TSX-308A/TSX-306A) V2.0Canon Medical Systems CorporationK253649Spectral CT Verida FamilyPhilips Medical Systems Technologies , Ltd.

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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