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FDA 510(k)

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

K-Number: K253578 · 2026-02-26

ApplicantAidoc Medical , Ltd.
Decision Date2026-02-26
Product CodeQAS
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

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.

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Other records listing Aidoc Medical , Ltd. 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.

K261317BriefCase-TriageK251195BriefCase-TriageK252970BriefCase-Triage: CARE Multi-triage CT BodyK253265BriefCase-TriageK251406BriefCase-TriageK250248BriefCase-Triage

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Related Devices (Code: QAS)

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.

K261085Rapid Vessel Occlusion (Rapid VO)iSchemaviewK260729Vascular Assist Occlusion Triage (VAOT) (v1.0)GuideAI HealthK261317BriefCase-TriageAidoc Medical , Ltd.K253163EFAI ERSUITE CT APPENDICITIS ASSESSMENT SYSTEM (APPEN-CT-100)Ever Fortune.Ai, Co., Ltd.K252421JLK-NCCTJLK, Inc.K253818Annalise EnterpriseHarrison-AI Medical Pty, Ltd.

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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