BriefCase-Quantification
K231631Aidoc Medical, Ltd. · cleared 2023-11-28 · product code JAK · Radiology
Premarket evidence — what FDA accepted
source quote (p.4)
“BriefCase-Quantification is a standalone software as a medical device intended for use in the analysis of non-cardiac-gated non-contrast CT (NCCT) images that include the heart to assist hospital networks and appropriately trained medical specialists.”
source quote (p.5)
“All devices are artificial intelligence, deep-learning algorithms incorporating software packages for use with compliant scanners, PACS, and radiology workstations.”
source quote (p.9)
“The cases collected for the pivotal dataset were all distinct in time or center from the cases used to train the algorithm.”
Validation studies (1)
Retrospective clinical
n=433 cases · 6 site(s)
endpoints: overall agreement between the ground truth and algorithm across estimated CAC scores; algorithm performance between the ground truth and algorithm, in individual categories
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
- 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
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (GE Medical Systems, LLC, initiated 2026-03-26): "GE HealthCare has become aware of a potential security vulnerability impacting AW Server deployed via Edison Health Link (EHL) based CT Smart Subscription used in conjunction with " Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98738
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2026-03-07): "Philips has identified three software issues: 1. During a continuous CT (CCT) scan, there is the potential that the Gantry could remain at the current scan position after pressing" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98588
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (Siemens Medical Solutions USA, Inc, initiated 2025-12-19): "To remove the software applications from certain CT systems as the applications have not received FDA 510(k) clearance." Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:98206
- recall_reason_pattern
Software/algorithm-related recall in product code JAK (PHILIPS MEDICAL SYSTEMS, initiated 2025-09-25): "Issue 1: The potential for unintentional continued gantry/couch movement when a specific button series is used requiring use of manual stop. Issue 2. When performing a helical/Axia" Recalling firm is another firm in the same product code.
first seen 2026-07-08 · recall res_event_number:97699
- …and 5 more.
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).