Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by 4Dmedical Limited. It received FDA 510(k) clearance on 2023-11-16 under approval 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. It is manufactured by 4Dmedical Limited. The 510(k) number is K232392.

When was CT Lung Ventilation Analysis Software (CT:V) approved by the FDA?

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

What company makes CT Lung Ventilation Analysis Software (CT:V)?

CT Lung Ventilation Analysis Software (CT:V) is manufactured by 4Dmedical Limited.

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

NCT07606495 Impact on Prognosis of Increased Sleep Quality Obtained by Personalized Night-time Nursing Care in Critically Ill Patients NOT_YET_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT07601828 Oxygen Delivery Index (ODIN) Study NOT_YET_RECRUITING NCT02091518 Development and Evaluation of Magnetic Resonance Imaging Acquisition and Analysis Methods ENROLLING_BY_INVITATION NCT07585019 Ventilator Study in the NICU NOT_YET_RECRUITING NCT07179146 A Comparison Of Dental Arch Analysis Using 3d Digital Scanning Versus Conventional Methods In Children COMPLETED

Related PubMed Literature

PMID: 41938602 AI-enabled cardiovascular devices: a lifecycle playbook for evidence, change control, and post-market assurance. Frontiers in digital health (2026) PMID: 41714355 The AI Act and the MDR post-market requirements for semiautonomous AI SaMD: a radiology case study in prostate cancer. Abdominal radiology (New York) (2026) PMID: 41533310 Scoping review of regulatory transparency in AI-based radiology software: analysis of PMDA-approved SaMD products. Japanese journal of radiology (2026) PMID: 41476571 Digital pathology imaging artificial intelligence in cancer research and clinical trials: An NCI workshop report. Journal of pathology informatics (2026)

Other Devices by 4Dmedical Limited

K251484CT:VQ

Related Devices (Code: JAK)

K162302Somatom Confidence ® RT ProSiemens Medical Solutions USA, Inc. K163213Revolution CTGe Medical Systems, LLC K161157Vitrea CT Dual Energy Image ViewVital Images, Inc. K160723OnSight 3D Extremity SystemCarestream Health, Inc. K161196SOMATOM DriveSiemens Medical Solutions USA, Inc. K161748SUPRIA w/guideShot OptionHitachi Medical Systems America, Inc.

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.

↑