BriefCase-Quantification

K232083

Aidoc Medical, Ltd. · cleared 2023-11-13 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.4)

“BriefCase-Quantification is a radiological image management and processing device. The software consists of a single module based on an algorithm programmed component and is intended to run on a linux-based server in a cloud environment.”

Algorithmartificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations. The core processing component is coupled with a pre-processing module to prepare input digital imaging and communications in medicine (DICOMS) for processing by the CNNs and a post-processing module to convert the output into visual and tabular output for users.

source quote (p.5)

“Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations. The core processing component is coupled with a pre-processing module to prepare input digital imaging and communications in medicine (DICOMS) for processing by the CNNs and a post-processing module to convert the output into visual and tabular output for users.”

Adaptive (vs locked)FDA source did not state this

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=284 cases · 6 site(s)

endpoints: mean absolute error between the ground truth measurement and algorithm; agreement between the ground truth compared to the algorithm output

Reported performance (0 observations)

FDA source did not state a quantitative performance metric — non-reporting is itself the signal.

Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.

Predicate network

Postmarket — what happened after clearance

recalls in product code, 24mo

MAUDE reports in code, 12mo

—

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K242203 (decision 2024-11-22) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Quantification") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242203
re_clearance
The FDA AI/ML device list shows a newer 510(k) K241112 (decision 2024-05-15) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Quantification") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K241112
re_clearance
The FDA AI/ML device list shows a newer 510(k) K231631 (decision 2023-11-28) from Aidoc Medical, Ltd. for a matching device line ("BriefCase-Quantification") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K231631

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.

Reimbursement — how devices like this got paid

Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).