DELTAVIEW MODEL 2.1

K111776

RIVERAIN MEDICAL GROUP,LLC · cleared 2011-12-28 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.1)

“DeltaView is a dedicated post-processing application which registers current and prior chest exams to provide an image that shows areas of change.”

Algorithmmathematical model using advanced image processing and pattern recognition methods for generating a difference image by registering and subtracting normalized, bone suppressed image pairs.

source quote (p.2)

“DeltaView is a mathematical model of the current medical practice of manually comparing radiographic images. ... DeltaView facilitates the comparison process through the automated formation of a difference image, by registering and subtracting a difference of normalized, bone suppressed image pairs. DeltaView achieves this using a variety of advanced image processing and pattern recognition methods.”

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)

Reader study (MRMC)

sample size not stated

endpoints: evaluate radiologists' diagnostic performance in the detection of actionable lung nodules on chest radiographs with and without the usage of DeltaView.; demonstrate that a radiologist's results when using DeltaView images are superior to the radiologist's results when using standard prior and current AP/PA x-ray image pairs alone.; Localized Receiver Operating Characteristic (LROC) Analysis and analyses for Sensitivity, Specificity, and Positive and Negative Predictive Value were performed.

Reported performance (1 observation)

aurocas written: “auc”0.536

source quote (p.3)

“The area under the LROC curve (AUCLROC) increased from 0.477 to 0.536 (12.4%) (p = 2.9E-05)”

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

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).