densitas densityai
K192973Densitas, Inc. · cleared 2020-02-19 · product code LLZ · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Densitas densityai™ is a software application intended for use with compatible full field digital mammography and digital breast tomosynthesis systems. Densitas densityai™ provides an ACR BI-RADS Atlas 5th Edition breast density category to aid interpreting physicians in the assessment of breast tissue composition. Densitas densityai™ produces adjunctive information. It is not a diagnostic aid.”
source quote (p.5)
“The software processes the data according to proprietary algorithms and generates a Breast Density Grade in accordance with the American College of Radiology's Breast Imaging Reporting and Data System (BI-RADS) 5th edition density classification scale.”
Validation studies (2)
Bench
sample size not stated
standards: ISO 14971
Reader study (MRMC)
n=796 cases
endpoints: Reliability was assessed using the Pearson's Correlation Coefficient by comparing the densitas densityai™ percent density, dense breast area and total area measurements for Left and Right breasts.; Accuracy was assessed by validating densitas densityai™ percent density and total area measurements.; Accuracy was further assessed by validating the Breast Density Grade assessments to known Breast Density Grade assessments using the Kappa statistic.; Reproducibility was assessed with the Pearson Correlation Coefficient by running the algorithm twice over the same set of images.; The inverse relationship between breast density and age was assessed by calculating the Pearson's Correlation Coefficient between densitas densityai™ percent density measures and age at time of screening for data sets where age was known.
Reported performance (10 observations)
source quote (p.9)
“Table 3 - Confusion matrix for the density software and the reference standard using the BI-RADS 5th edition breast density scale grouped into Fatty (A,B) and Dense (C,D) density categories (all scan types)”
source quote (p.9)
“Table 3 - Confusion matrix for the density software and the reference standard using the BI-RADS 5th edition breast density scale grouped into Fatty (A,B) and Dense (C,D) density categories (all scan types)”
source quote (p.8)
“n=796; Kappa 0.87 (0.87, 0.87)”
source quote (p.8)
“Accuracy 78%”
source quote (p.8)
“Accuracy 76%”
source quote (p.8)
“Accuracy 83%”
source quote (p.8)
“Accuracy 89%”
source quote (p.9)
“n=796; Kappa 0.84 (0.8, 0.88)”
source quote (p.9)
“Accuracy 88%”
source quote (p.9)
“Accuracy 96%”
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
- 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). 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).