Ezra Flash

K230264

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

FDA 510(k) summary for Ezra Flash (K230264)

Constat organizes this clearance into predicate context, validation evidence, reported performance, postmarket signals, and reimbursement links. Each extracted claim stays tied to the public FDA source; missing fields remain explicitly unstated.

Validation studies
1
Cited predicates
1
Performance observations
0
Product code
LLZ
Official FDA 510(k) database record ↗FDA 510(k) source PDF ↗

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.”
PCCPNo
Cybersecurity addressedNo

Validation studies (1)

Standalone

sample size not stated

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

standards: ISO 14971:2019, IEC 62304 Edition 1.1: 2015, NEMA PS 3.1-3.20 (2021e)

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

25
recalls in product code, 24mo
397
MAUDE reports in code, 12mo
+963%
vs code's own 3-yr baseline
32
drift signals on this device
  • predicate_cohort_contagion

    K230264 shares predicate K203182 with K242334 (Ezra Flash), whose product code QIH recorded 1 recall event(s) in the trailing 24 months.

    first seen 2026-09-02 · predicate:K203182 sibling:K242334

  • 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

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-07-22): "Software issue may cause measurements to be displayed inaccurately." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99520

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (FUJIFILM Healthcare Americas Corporation, initiated 2026-07-22): "Software issue may cause the ruler measurement to be inaccurate." Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99529

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Merge Healthcare, Inc., initiated 2026-06-30): "Merge Healthcare has identified a potential issue that may cause thumbnails from a previously opened patient study to be displayed in the Thumbnail Bar while a different patient st" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99391

  • recall_reason_pattern

    Software/algorithm-related recall in product code LLZ (Boston Scientific Corporation, initiated 2026-06-19): "Software anomaly occurs when a user adds one or more vials to the cart and subsequently returns to the Activity Calculator to modify one or more input. When a user modifies an inpu" Recalling firm is another firm in the same product code.

    first seen 2026-09-02 · recall res_event_number:99236

  • …and 26 more.

Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device); a recall is shown as device-attributed only when the recall record itself lists this clearance number. Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-09-02.

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).

Applicable FDA guidance — what the submission is measured against

FDA guidance documents and guiding principles applicable to 510(k) AI/ML devices in the Radiology panel. A curated reference index, not legal or regulatory advice — each item states its own status, and a draft is never binding.

Applicability is derived from the device's FDA advisory panel and pathway — cross-cutting guidances apply to every AI/ML device; panel-specific ones are flagged. Titles, dates, and links verified against fda.gov as of July 2026.

Related FDA clearances

More AI/ML devices under product code LLZ

These are recent clearances in the same FDA product-code category. Shared classification does not by itself make a device an appropriate predicate.

Acorn 3D Software (AC-SEG-4009); Acorn 3DP Model (AC-101-XX)

K251532

Mighty Oak Medical

cleared 2025-11-03

SurgiTwin

K250290

Twinsight

cleared 2025-08-29

Neuro Insight V1.0

K243681

Olea Medical S.A.S.

cleared 2025-07-23

GyriCalc (Version 1.0.0)

K250686

NeuroSpectrum Insights Corp.

cleared 2025-07-22

VersaViewer

K243651

GE Medical Systems SCS

cleared 2025-04-21

brAIn™ Shoulder Positioning

K243292

Avatar Medical

cleared 2025-03-20

aiCockpit AI Viewer

K241546

Fovia, Inc.

cleared 2025-02-26

QuickRad

K242838

Aikenist Technologies Pvt Ltd

cleared 2025-02-21

Constat Precedent · public FDA/CMS data · descriptive decision-support, not regulatory or reimbursement advice. Share this page: constat.dev/precedent/device/K230264