All AI devices
US

BriefCase

๐Ÿ‡ฎ๐Ÿ‡ฑAidoc Medical , Ltd. ยท Lesion detection/diagnosis software

What it does

Marks areas of interest on multi-modality images to support the radiologist's read as a second pair of eyes; the radiologist makes the call.

Who it's for

Radiologists who want a detection aid on these studies and programs aiming to improve consistency.

Reported performance

No sensitivity / specificity / AUC was disclosed in the available summary. Many summaries report no standalone metrics โ€” we note that honestly rather than imply a number.

Performance numbers are manufacturer-reported and often single-site; treat them as a starting point, not an independent benchmark.

FDA

Pathway510(k)
Submission #K222692
Product codeQFM
Decision dateDec 5, 2022
PanelRadiology
FDA recordaccessdata

EU (CE)

Statusunknown
Risk classโ€”
Notified bodyโ€”
EMDN codeโ€”
Basic UDI-DIโ€”
AI Act classโ€”

EU coverage is filling out through 2026; absence here doesn't mean a device isn't CE-marked.

Vendor

Cite this page

RadPigeon. "BriefCase (Aidoc Medical , Ltd.)." AI Devices registry. https://radpigeon.news/ai/device/briefcase-2

Last updated Jun 29, 2026. Information only โ€” not clinical advice. Summaries are RadPigeon's own wording.