PeekMed web

K250042

Peek Health, S.A. · cleared 2025-03-19 · product code QIH · Radiology

FDA 510(k) summary for PeekMed web (K250042)

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
10
Product code
QIH
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.6)
“Being software it does not interact with any part of the body of the user and/or patient.”
AlgorithmML models for segmentation, landmarking, classification, and detection
source quote (p.14)
“ML models incorporated into the PeekMed web were also developed, trained, tested, and externally validated for their performance according to the internal procedures.”
Adaptive (vs locked)No
source quote (p.14)
“A dedicated validation dataset containing different data from the ML development dataset was used. Specifically, the validation dataset was not a sampling of the development dataset, has never been used for the algorithm training or for tunning the algorithm, and leakage between development and validation data sets did not occur.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Retrospective clinical

n=4,755 cases

endpoints: DICE is no less than 90%; HD-95 is no more than 8; STD DICE is between +/- 10%; Precision is more than 85%; Recall is more than 90%; MRE is no more than 7mm; STD MRE is between +/- 5mm; Accuracy is no less than 90%; Precision is no less than 85%; Recall is no less than 90%; F1 score is no less than 90%; MAP is no less than 90%; Precision is no less than 85%; Recall is no less than 90%

Reported performance (10 observations)

diceas written: “DICE”stated without valueCI no less than 90%
source quote (p.15)
“DICE is no less than 90%”
diceas written: “STD DICE”stated without valueCI between +/- 10%
source quote (p.15)
“STD DICE is between +/- 10%”
ppvas written: “Precision (Segmentation)”stated without valueCI more than 85%
source quote (p.15)
“Precision is more than 85%”
sensitivityas written: “Recall (Segmentation)”stated without valueCI more than 90%
source quote (p.15)
“Recall is more than 90%”
accuracyas written: “Accuracy (Classification)”stated without valueCI no less than 90%
source quote (p.15)
“Accuracy is no less than 90%.”
ppvas written: “Precision (Classification)”stated without valueCI no less than 85%
source quote (p.15)
“Precision is no less than 85%”
sensitivityas written: “Recall (Classification)”stated without valueCI no less than 90%
source quote (p.15)
“Recall is no less than 90%”
f1as written: “F1 score”stated without valueCI no less than 90%
source quote (p.15)
“F1 score is no less than 90%”
ppvas written: “Precision (Detection)”stated without valueCI no less than 85%
source quote (p.15)
“Precision is no less than 85%”
sensitivityas written: “Recall (Detection)”stated without valueCI no less than 90%
source quote (p.15)
“Recall is no less than 90%”

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
5
drift signals on this device
  • predicate_cohort_contagion

    K250042 shares predicate K240926 with K250290 (SurgiTwin), whose product code LLZ recorded 48 recall event(s) in the trailing 24 months.

    first seen 2026-07-15 · predicate:K240926 sibling:K250290

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252856 (decision 2025-12-22) from Peek Health, S.A. for a matching device line ("PeekMed web") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252856

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K252452 (decision 2025-11-12) from Peek Health, S.A. for a matching device line ("PeekMed web") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K252452

  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K251096 (decision 2025-07-14) from Peek Health, S.A. for a matching device line ("PeekMed web") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K251096

  • recall_reason_pattern

    Software/algorithm-related recall in product code QIH (PIE Medical Imaging B.V., initiated 2026-05-07): "User measurement value reported by diagnostic bioimaging software intended to measure/visualize cardiovascular structures may be larger (0.8% to 34.4%) than the actual anatomical d" Recalling firm is another firm in the same product code.

    first seen 2026-08-26 · recall res_event_number:98930

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 QIH

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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Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K250042