35 devices · 2 companies · 2018 to 2026

Aidoc Medical , Ltd.: AI-enabled devices on FDA's list

35 devices from Aidoc Medical , Ltd., 2018 to 2026, from 2 companies across 4 product codes. Each record carries FDA's decision, the Indications for Use statement verbatim where the public document carries one (35 of 35 here), the regulation, and MAUDE report counts by product code.

Retrieved from FDA public records.

Product codes from Aidoc Medical , Ltd.

Every device, newest decision first

Aidoc Medical , Ltd. · 35 devices
DecisionDevicePanelProduct codeFDA
BriefCase-TriageK261317 · 510(k)RadiologyQASdatabase entry
BriefCase-Triage: CARE Multi-Triage CT for PneumK253578 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK251195 · 510(k)RadiologyQASdatabase entry
BriefCase-Triage: CARE Multi-triage CT BodyK252970 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK253265 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK251406 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK250248 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK243548 · 510(k)RadiologyQFMdatabase entry
BriefCase-QuantificationK242203 · 510(k)RadiologyQIHdatabase entry
BriefCase-TriageK242837 · 510(k)RadiologyQASdatabase entry
BriefCase-TriageK241727 · 510(k)RadiologyQASdatabase entry
BriefCase-QuantificationK241112 · 510(k)RadiologyQIHdatabase entry
BriefCase-QuantificationK231631 · 510(k)RadiologyJAKdatabase entry
BriefCase-QuantificationK232083 · 510(k)RadiologyQIHdatabase entry
BriefCase-QuantificationK230534 · 510(k)RadiologyQIHdatabase entry
BriefCase-TriageK232751 · 510(k)RadiologyQASdatabase entry
BriefCaseK230020 · 510(k)RadiologyQFMdatabase entry
BriefCaseK222692 · 510(k)RadiologyQFMdatabase entry
BriefCaseK221330 · 510(k)RadiologyQASdatabase entry
BriefCaseK220709 · 510(k)RadiologyQASdatabase entry
BriefCaseK222329 · 510(k)RadiologyQASdatabase entry
BriefCaseK222277 · 510(k)RadiologyQASdatabase entry
BriefCaseK221314 · 510(k)RadiologyQASdatabase entry
BriefCaseK221240 · 510(k)RadiologyQASdatabase entry
BriefCaseK213886 · 510(k)RadiologyQASdatabase entry
BriefCaseK213721 · 510(k)RadiologyQASdatabase entry
BriefCaseK214043 · 510(k)RadiologyQFMdatabase entry
BriefCase, RIB Fractures TriageK202992 · 510(k)RadiologyQFMdatabase entry
BriefCaseK203508 · 510(k)RadiologyQASdatabase entry
BriefCaseK201020 · 510(k)RadiologyQASdatabase entry
BriefCaseK193298 · 510(k)RadiologyQASdatabase entry
BriefCaseK192383 · 510(k)RadiologyQASdatabase entry
BriefCaseK190896 · 510(k)RadiologyQASdatabase entry
BriefCaseK190072 · 510(k)RadiologyQASdatabase entry
BriefCaseK180647 · 510(k)RadiologyQASdatabase entry

Every company in the record, the whole record of FDA AI-enabled medical devices, or what Apodicta does on a medical record.

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Every device here is authorized for a stated use. See a record read against what it must prove, on your own file.

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