Volpara Imaging Software

K182310

Volpara Health Technologies Limited · cleared 2018-09-21 · 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.”

AlgorithmThe assessment takes the form of generating and validating density maps wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based statistics are computed as follows: volume of fibroglandular tissue in cm³, volume of breast in cm³, the volumetric breast density (the percentage of fibroglandular tissue in breast) average thickness of dense tissue in cm, maximum thickness of dense tissue in cm, maximum volume of dense tissue above any 1cm² square region (or "focal density"). From the volumetric breast density, a BI-RADS 4th Edition and 5th Edition breast density category can be attained by applying thresholds set by the software.

source quote (p.5)

“The assessment takes the form of generating and validating density maps wherein the value at each pixel represents the thickness of fibroglandular tissue between that pixel and the x-ray source. From the density maps various quantitative density-map based statistics are computed as follows: volume of fibroglandular tissue in cm³, volume of breast in cm³, the volumetric breast density (the percentage of fibroglandular tissue in breast) average thickness of dense tissue in cm, maximum thickness of dense tissue in cm, maximum volume of dense tissue above any 1cm² square region (or "focal density"). From the volumetric breast density, a BI-RADS 4th Edition and 5th Edition breast density category can be attained by applying thresholds set by the software.”

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)

Bench

sample size not stated

standards: ISO 14971:2012 Medical devices – Application of risk management to medical devices, ISO 62304-2006 Software Life Cycle Processes, DICOM 2015

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

recalls in product code, 24mo

295

MAUDE reports in code, 12mo

+683%

vs code's own 3-yr baseline

drift signals on this device

re_clearance
The FDA AI/ML device list shows a newer 510(k) K211279 (decision 2021-07-27) from Volpara Health Technologies Limited for a matching device line ("Volpara Imaging Software") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K211279
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
…and 21 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). 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).