Ezra Flash

K230264

Ezra AI, Inc. · cleared 2023-04-13 · product code LLZ · Radiology

Premarket evidence — what FDA accepted

Device typesamd

source quote (p.5)

“Ezra Flash is a Software as a Medical Device (SaMD) consisting of a software algorithm that enhances images of the head region taken by MRI scanners.”

Algorithmconvolutional neural network-based filtering

source quote (p.7)

“Ezra Flash software implements an image enhancement algorithm using a convolutional neural network-based filtering. Original images are enhanced by running through a cascade of filter banks, where thresholding and scaling operations are applied. These filters result in a single machine learning model that reduces noise. The parameters of the filters were obtained through an image-guided optimization process.”

Adaptive (vs locked)No

source quote (p.7)

“These filters result in a single machine learning model that reduces noise.”

PCCPFDA source did not state this

Cybersecurity addressedFDA source did not state this

Validation studies (2)

Standalone

sample size not stated

endpoints: Signal-to-Noise Ratio (SNR); Contrast-to-Noise Ratio (CNR)

standards: ISO 14971:2019 - Medical Devices - Application of risk management to medical devices, IEC 62304 Edition 1.1: 2015 - Medical device software - Software life cycle processes, NEMA PS 3.1-3.20 (2021e) - Digital Imaging and Communications in Medicine (DICOM) set

Reader study (MRMC)

sample size not stated

endpoints: Image Quality - Perceived Noise

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) K242334 (decision 2025-01-02) from Ezra AI, Inc. for a matching device line ("Ezra Flash") — a new clearance for the same line is a change event.
first seen 2026-07-08 · k_number:K242334
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).