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FDA 510(k)

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite

K-Number: K223491 · 2023-05-25

ApplicantGe Medical Systems, LLC
Decision Date2023-05-25
Product CodeQBS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is a medical device manufactured by Ge Medical Systems, LLC. It received FDA 510(k) clearance on 2023-05-25 under approval number K223491. The device is classified under product code QBS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is a medical device that received FDA 510(k) clearance on 2023-05-25. It is manufactured by Ge Medical Systems, LLC. The 510(k) number is K223491.

When was Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite approved by the FDA?

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite received FDA 510(k) clearance on 2023-05-25, under approval number K223491.

What company makes Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is manufactured by Ge Medical Systems, LLC.

What is the FDA product code for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

The FDA product code for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite is QBS.

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Related PubMed Literature

PMID: 41153261 From Lab to Clinic: Artificial Intelligence with Spectroscopic Liquid Biopsies. Diagnostics (Basel, Switzerland) (2025) PMID: 40035968 Chemical Characterization in Medical Device Evaluation: Current Practices, Regulatory Requirements, and Future Directions. Annals of biomedical engineering (2025)

Other Devices by Ge Medical Systems, LLC

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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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