FDA 510(k)

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device

Número K: K253578 · 2026-02-26

Data da decisão2026-02-26

Código do produtoQAS

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is the device name listed in this FDA 510(k) record. The listed applicant is Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2026-02-26 under 510(k) number K253578. The device is classified under product code QAS. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device?

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is a medical device that received FDA 510(k) clearance on 2026-02-26. The listed applicant is Aidoc Medical , Ltd.. The 510(k) number is K253578.

When did BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device receive FDA 510(k) clearance?

BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device received FDA 510(k) clearance on 2026-02-26, under 510(k) number K253578.

Who is the listed applicant for BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device?

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

What is the FDA product code for BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device?

The FDA product code for BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device is QAS.

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Outros registros que listam Aidoc Medical , Ltd. como candidato(a)

K261317BriefCase-Triage K251195BriefCase-Triage K252970BriefCase-Triage: CARE Multi-triage CT Body K253265BriefCase-Triage K251406BriefCase-Triage K250248BriefCase-Triage

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Dispositivos Relacionados (Código: QAS)

K260906a2z-Abdo-TriageA2z Radiology Ai, Inc.K261085Rapid Vessel Occlusion (Rapid VO)iSchemaview K260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI Health K261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.

Fonte oficial

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