BriefCase-Quantification

K230534

Aidoc Medical, Ltd. · cleared 2023-11-08 · product code QIH · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“BriefCase-Quantification is a radiological image management and processing system software indicated for use in the analysis of CT exams with contrast, that include the abdominal aorta, in adults or transitional adolescents aged 18 and older.”
Algorithmartificial intelligence, deep-learning algorithms
source quote (p.5)
“All 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
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=160 cases · 6 site(s)

endpoints: evaluate the software's performance in providing maximum axial diameter measurements of the abdominal aorta

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
4
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

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K232083 (decision 2023-11-13) 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:K232083

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/K230534