Volpara Imaging Software

K153427

Matakina Technology LTD · cleared 2016-01-07 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd
source quote (p.3)
“Volpara is a software application intended for use with the raw data from digital breast x-ray systems, including tomosynthesis. Volpara calculates and quantifies a density map and from that determines volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates.”
Algorithmgenerates and validates density maps where the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source, then computes quantitative density-map based statistics.
source quote (p.6)
“The Volpara 1.5.2 software provides volumetric assessment of digital x-ray images of the breast, including in that definition both digital mammograms and raw tomosynthesis projections. The assessment takes the form of generating and validating density maps where the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From those density maps various quantitative density-map based statistics are computed, namely: volume of fibroglandular tissue in cm³, volume of breast in cm³, the volumetric breast density in %, a BI-RADS 4th Edition or 5th Edition breast density category, average thickness of dense tissue, maximum thickness of dense tissue, maximum volume of dense tissue above any 1cm² square region”
Adaptive (vs locked)FDA source did not state this
PCCPNo
Cybersecurity addressedNo

Validation studies (9)

Bench

sample size not stated

endpoints: Measurement accuracy

Bench

sample size not stated

endpoints: Relationship to ground truth (fibroglandular tissue estimates)

Bench

sample size not stated

endpoints: Reproducibility; comparison with expected decrease in breast density with age

Bench

sample size not stated

endpoints: Reproducibility; similarity of results for left/right breasts and CC/MLO views

Bench

sample size not stated

endpoints: Reproducibility; similarity of results from GE and Hologic systems

Bench

sample size not stated

endpoints: Reproducibility; similarity of results from GE, Hologic, Siemens tomosynthesis/mammography modes

Reader study (MRMC)

sample size not stated

endpoints: Relationship to visual assessment (BI-RADS density category)

Prospective clinical

sample size not stated

endpoints: Integration into existing systems; usability for target users

Prospective clinical

sample size not stated

endpoints: Collection of minimum, average, and maximum Volpara breast densities; comparison to other existing databases

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

48
recalls in product code, 24mo
295
MAUDE reports in code, 12mo
+683%
vs code's own 3-yr baseline
26
drift signals on this device
  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems SCS, initiated 2026-05-08): "GE HealthCare has become aware of a context synchronization issue in AW Server 3.2 ext. 6.5. When a user selects a patient or exam in the AW Server Web Client worklist and launches" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:99042

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. Veenpluis 4-6 Best Netherlands, initiated 2026-03-05): "Potential that mis-ordered frames in Vue Motion during dynamic cine runs may cause images frames to display out of sequence." Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (GE Medical Systems, LLC, initiated 2026-01-30): "There is a potential cybersecurity vulnerability affecting certain versions of Centricity Universal Viewer. User login credentials may be exposed on the local client workstation, w" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98428

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Focalyx Technologies, LLC., initiated 2025-12-23): "Software device that is an accessory for image-guided interventional and diagnostic procedures involving prostate has accessories that may not function properly with Windows 10, wh" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:98137

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (DICOM Grid, Inc., initiated 2025-11-18): "Software intended to aid in diagnosing conditions, planning treatments, visualizing anatomical structures has a bug that, if all of following are met: Viewing images in InteleShare" Recalling firm is another firm in the same product code.

    first seen 2026-07-08 · recall res_event_number:97993

  • …and 20 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 2026-07-08.

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.

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K153427