HealthCCSng

K241440

Nano-X AI Ltd. · cleared 2024-08-19 · product code JAK · Radiology

FDA 510(k) summary for HealthCCSng (K241440)

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
1
Cited predicates
1
Performance observations
0
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)
“HealthCCSng product is a software device that automatically estimates the coronary artery calcium category from non-cardiac-gated adult CT scans.”
Algorithmartificial intelligence algorithm for deep-learning-based segmentation
source quote (p.10)
“Deep-learning-based segmentation of the heart”
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=436 cases · 4 site(s)

endpoints: overall agreement between HealthCCSng coronary calcium category and the ground truth category; Agreement for the Zero category; Agreement for the Low category; Agreement for the Medium category; Agreement for the High category; Pearson's correlation coefficient between the GT and HealthCCSng scores

standards: Software Development and Validation & Verification Process, User Requirements and Federal Regulations and Guidance documents, “Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices"

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

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

    K241440 shares predicate K210085 with K233211 (AVIEW CAC), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-08-26 · predicate:K210085 sibling:K233211

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code JAK (Philips North America Llc, initiated 2025-05-29): "Devices with affected software may experience two unintended motion issues that may lead to contact between the Gantry or table with the operator or patient, along with additional " Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97010

  • …and 4 more.

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.

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True Definition DL

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CT Rembra RT; CT Areta RT; CT Rembra

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cleared 2026-03-23

SOMATOM X.cite; SOMATOM X.ceed

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cleared 2026-03-20

Photonova Spectra, Photonova Spectra Select

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Aquilion ServeSP (TSX-307B) V2.0

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Bunkerhill Contrast AVC

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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/K241440