FDA 510(k)

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

Numéro K : K223491 · 2023-05-25

Date de décision2023-05-25

Code produitQBS

Comité consultatifRA

DécisionSubstantially Equivalent

Résumé du dispositif

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

Questions fréquentes

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. The listed applicant is Ge Medical Systems, LLC. The 510(k) number is K223491.

When did Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite receive FDA 510(k) clearance?

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 510(k) number K223491.

Who is the listed applicant for Critical Care Suite with Pneumothorax Detection AI Algorithm, Critical Care Suite 2.1, Critical Care Suite?

The FDA 510(k) record lists Ge Medical Systems, LLC as the applicant. This does not by itself establish the device manufacturer.

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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