AV Cardiac CT

K260169

Philips Medical Systems Nederland B.V. · cleared 2026-03-05 · product code JAK · Radiology

FDA 510(k) summary for AV Cardiac CT (K260169)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
3
Cited predicates
2
Performance observations
3
Product code
JAK
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.5)
“AV Cardiac CT is a standalone, software-only medical device intended for advanced visualization, post-processing, and analysis of cardiac computed tomography (CT) datasets.”
AlgorithmAI-based step, CNN - deep learning component, model based, KNN model
source quote (p.6)
“Algorithms that are new or updated in the subject device include automated coronary centerline extraction (with an Al-based step), vessel labeling, and coronary lumen segmentation. ... Includes new algorithm for centerline extraction (CNN - deep learning component included), updated vessel labelling algorithm (model based) and new lumen segmentation algorithm (KNN model).”
Adaptive (vs locked)No
source quote (p.6)
“All algorithm outputs are reviewable and editable by the user, and the device does not perform autonomous clinical interpretation.”
PCCPNo
Cybersecurity addressedNo

Validation studies (3)

Retrospective clinical

n=80 patients · 13 site(s)

endpoints: Overlap (OV); OV for the clinically relevant part (OT); average distance (AvgDist)

Retrospective clinical

sample size not stated

endpoints: sensitivity; precision

Retrospective clinical

n=80 patients · 10 site(s)

endpoints: Dice similarity coefficient (DSC); mean surface distance (MSD); Hausdorff distance (HD)

Reported performance (3 observations)

sensitivity0.91CI >0.85 (lower bound of 95% CI)
source quote (p.8)
“can be correctly labelled with an overall sensitivity of 0.91 and precision of 0.97. The lower bounds of 95% CI of both sensitivity and precision were >0.85.”
ppvas written: “precision”0.97CI >0.85 (lower bound of 95% CI)
source quote (p.8)
“can be correctly labelled with an overall sensitivity of 0.91 and precision of 0.97. The lower bounds of 95% CI of both sensitivity and precision were >0.85.”
diceas written: “Dice similarity coefficient (DSC)”0.83CI 0.81, 0.84 (98.3% CI)
source quote (p.8)
“DSC DSC>0.7 0.83 (0.81, 0.84)”

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

25
recalls in product code, 24mo
216
MAUDE reports in code, 12mo
-12%
vs code's own 3-yr baseline
10
drift signals on this device
  • predicate_cohort_contagion

    K260169 shares predicate K150665 with K253735 (AV Vascular), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K150665 sibling:K253735

  • 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 matches this device's applicant.

    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 matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:98588

  • 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 matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:97699

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Philips Medical Systems Nederland B.V. Veenpluis, initiated 2025-02-28): "Multiple problems identified with the software version leading to various scanning and image issues, and unintended device movement." Recalling firm matches this device's applicant.

    first seen 2026-07-08 · recall res_event_number:96423

  • 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

  • …and 4 more.

Recalls attributed to this device

  • Recalling firm matches this device's applicant (PHILIPS MEDICAL SYSTEMS) — same firm and product code, not necessarily this device · initiated 2026-06-11

    The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

    recall event 99352 (openFDA)

  • Recalling firm matches this device's applicant (PHILIPS MEDICAL SYSTEMS) — same firm and product code, not necessarily this device · initiated 2026-06-11

    The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

    recall event 99352 (openFDA)

  • Recalling firm matches this device's applicant (PHILIPS MEDICAL SYSTEMS) — same firm and product code, not necessarily this device · initiated 2026-06-11

    The clinical CT scan may not automatically trigger after the Bolus Tracking scan and may need to be triggered manually. Additional Bolus Tracking shots may occur. This may result in the clinical acquisition being inadequate for diagnosis, causing a potential for patient rescan and receiving additional radiation.

    recall event 99352 (openFDA)

  • Recalling firm matches this device's applicant (GE Medical Systems, LLC) — same firm and product code, not necessarily this device · 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 certain Revolution Apex, Revolution Ascend, and Revolution CT systems.

    recall event 98738 (openFDA)

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 2026-08-26.

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.

Related FDA clearances

More AI/ML devices under product code JAK

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Enhanced Boundary for PCCT

K253560

Ge Medical Systems, LLC

cleared 2026-06-24

Spectral CT Verida Family

K253649

Philips Medical Systems Technologies , Ltd.

cleared 2026-03-27

True Definition DL

K253686

Ge Healthcare Japan Corporation

cleared 2026-03-23

CT Rembra RT; CT Areta RT; CT Rembra

K252992

Philips Healthcare (Suzhou) Co., Ltd.

cleared 2026-03-23

SOMATOM X.cite; SOMATOM X.ceed

K253574

Siemens Medical Solutions USA, Inc.

cleared 2026-03-20

Photonova Spectra, Photonova Spectra Select

K253520

Ge Medical Systems, LLC

cleared 2026-03-20

Aquilion ServeSP (TSX-307B) V2.0

K260078

Canon Medical Systems Corporation

cleared 2026-03-13

Bunkerhill Contrast AVC

K260167

BunkerHill Health

cleared 2026-03-06

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K260169