Preview Shoulder

K210556

Genesis Software Innovations · cleared 2021-04-21 · product code QIH · Radiology

FDA 510(k) summary for Preview Shoulder (K210556)

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
2
Performance observations
0
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)
“The QIH device definition applies to picture archiving and communications systems that implement artificial intelligence (AI) including nonadaptive machine learning algorithms. Preview Shoulder utilizes an AI algorithm for reconstructing 3D bone model from the image data.”
AlgorithmAI algorithm for reconstructing 3D bone model from the image data
source quote (p.6)
“Preview Shoulder utilizes an AI algorithm for reconstructing 3D bone model from the image data.”
Adaptive (vs locked)No
source quote (p.6)
“The QIH device definition applies to picture archiving and communications systems that implement artificial intelligence (AI) including nonadaptive machine learning algorithms.”
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (1)

Bench

sample size not stated

endpoints: assess the safety and effectiveness of the device; demonstrate the processing of patient images to produce accurate and repeatable 3D reconstructed bones and surgical coordinates provided to the surgeon

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

1
recalls in product code, 24mo
4
MAUDE reports in code, 12mo
—
vs code's own 3-yr baseline
2
drift signals on this device
  • re_clearance

    The FDA AI/ML device list shows a newer 510(k) K240172 (decision 2024-04-04) from Genesis Software Innovations for a matching device line ("Preview Shoulder") — a new clearance for the same line is a change event.

    first seen 2026-07-08 · k_number:K240172

  • 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.

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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/K210556