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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 a medical device manufactured by Aidoc Medical , Ltd.. It received FDA 510(k) clearance on 2026-02-26 under approval 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. It is manufactured by Aidoc Medical , Ltd.. The 510(k) number is K253578.

When was BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture or dislocation device approved by the FDA?

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 approval number K253578.

What company makes 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 manufactured by Aidoc Medical , Ltd..

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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Related PubMed Literature

PMID: 42212181 Cybersecurity and Privacy Risks of Generative AI Mental-Health Chatbots: A Systematic Review and Regulatory Framework. Journal of multidisciplinary healthcare (2026) PMID: 42127028 Proposed standards for prosthetic foot reuse and considerations for donation of used prosthetic feet to low-and middle-income countries. PLOS global public health (2026) PMID: 42088337 Impact of Aneurysm Size and Flow Diverter Use on Outcomes After Endovascular Therapy of Unruptured Paraclinoid Aneurysms. Stroke (Hoboken, N.J.) (2026) PMID: 42024289 Signal Detection Using Change Point Analysis to Identify Safety Signals from Spontaneous Reports in Aortic Stent Grafts in Japan. Journal of medical systems (2026)

Other Devices by Aidoc Medical , Ltd.

K180647BriefCase K192383BriefCase K190896BriefCase K190072BriefCase K203508BriefCase K201020BriefCase

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Related Devices (Code: QAS)

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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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