QUANTRA
K142037HOLOGIC, INC. · cleared 2014-10-10 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Quantra™ is a software application intended for use with images acquired using digital breast x-ray systems. Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra also provides area breast density as a ratio of fibroglandular tissue area and total breast area estimates. Quantra segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra results for each image, breast, and subject, are intended to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid.”
source quote (p.3)
“Quantra calculates volumetric breast density as a ratio of fibroglandular tissue and total breast volume estimates. Quantra also provides area breast density as a ratio of fibroglandular tissue area and total breast area estimates. Quantra segregates breast density into categories, which may be useful in the reporting of consistent BI-RADS® breast composition categories as mandated by certain state regulations. The Quantra results for each image, breast, and subject, are intended to aid radiologists in the assessment of breast tissue composition. Quantra produces adjunctive information; it is not an interpretive or diagnostic aid. The Quantra 2.1 algorithm is updated to make it independent of certain acquisition parameters related to x-ray spectrum and tube output. Quantra 2.1 includes a new reference population with the more recent Hologic Selenia Dimensions image sets. The method to combine image level results for the per-breast and per-patient breast density measures are updated. Specifically, the results are combined by method of averaging versus maximum (in Quantra 2.0).”
Validation studies (4)
Bench
n=1 other
endpoints: measurement accuracy for thickness of fibroglandular tissue
Retrospective clinical
n=2 other
endpoints: reproducibility of the breast density measurement (Vbd)
Retrospective clinical
n=3 other
endpoints: statistical evaluation between CC and MLO views of the same breast and left and right breasts of the same women
Reader study (MRMC)
n=15 other
endpoints: compare the reader BI-RADS scores to the q_abd, Q_abd, Vbd and Abd measures
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
- re_clearance
The FDA AI/ML device list shows a newer 510(k) K163623 (decision 2017-10-20) from HOLOGIC, INC. for a matching device line ("Quantra") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K163623
- 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).