MRCP+ v1.0

K183133

Perspectum Diagnostics Ltd · cleared 2019-01-09 · product code LLZ · Radiology

FDA 510(k) summary for MRCP+ v1.0 (K183133)

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
5
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.4)
“MRCP+v1 is a standalone software device.”
AlgorithmCalculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. Includes tools for interactive segmentation and labelling of the biliary system and tubular structures. Allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.
source quote (p.5)
“MRCP+v1 calculates quantitative three-dimensional biliary system models that enable measurement of bile duct widths and automatic detection of regions of variation (ROV) of tubular structures. MRCP+v1 includes tools for interactive segmentation and labelling of the biliary system and tubular structures. MRCP+v1 allows for regional volumetric analysis of segmented tree-like, tubular structures and the gallbladder.”
Adaptive (vs locked)FDA source did not state this
PCCPFDA source did not state this
Cybersecurity addressedFDA source did not state this

Validation studies (5)

Bench

sample size not stated

endpoints: 95% CI Upper Limit of Agreement; 95% CI Lower Limit of Agreement

standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485

Bench

sample size not stated

endpoints: 95% CI Upper Limit of Agreement; 95% CI Lower Limit of Agreement

standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485

Bench

sample size not stated

endpoints: Upper Limit of Agreement (mm); Lower Limit of Agreement (mm)

standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485

Standalone

sample size not stated

endpoints: 95% CI Upper Limit of Agreement; 95% CI Lower Limit of Agreement

standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485

Reader study (MRMC)

n=2 other

endpoints: 95% CI Upper Limit of Agreement; 95% CI Lower Limit of Agreement

standards: IEC 62304, IEC 62366-1, DICOM 3.0, ISO 14971, ISO 13485

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
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
31
drift signals on this device
  • predicate_cohort_contagion

    K183133 shares predicate K131498 with K241543 (DrAid™ for Liver Segmentation), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K131498 sibling:K241543

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • adverse_event_inflection

    MAUDE adverse-event reports for product code LLZ: 295 in the 12 months ending 2026-06, vs a 37.7/12mo average over the prior 3 windows (+683%). Code-level count — reports are not attributed to this specific device.

    first seen 2026-07-08 · openFDA /device/event.json count=date_received product_code=LLZ

  • …and 25 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 2026-09-02.

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

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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/K183133