BriefCase-Quantification

K241112

Aidoc Medical, Ltd. · cleared 2024-05-15 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“BriefCase-Quantification is a radiological medical 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
source quote (p.5)
“Both devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations.”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Retrospective clinical

n=162 cases · 6 site(s)

endpoints: mean absolute error between the ground truth measurement and algorithm

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

0
recalls in product code, 24mo
3
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
1
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

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. 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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K241112