FDA 510(k)

ブリーフケース・トライアージ：CARE Multi-Triage CT for 肺気胸；心包炎；大動脈瘤；肩関節骨折または脱臼デバイス

K番号: K253578 · 2026-02-26

決定日2026-02-26

製品コードQAS

諮問委員会RA （注：由于原文中未提供具体的医疗设备监管文本内容，因此无法进行翻译。请提供具体的文本内容以便进行翻译。）

決定大幅同等

医療機器の概要

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.

よくある質問

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.

申請者としてAidoc Medical , Ltd.を記載するその他の記録

K261317ブリーフケース・トリアージ K251195ブリーフケース・トリアージ K252970ブリーフケース・トライアージ：CAREマルチトライアージCTボディ K253265ブリーフケース・トリアージ K251406ブリーフケース・トリアージ K250248ブリーフケース・トリアージ

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公式ソース

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