510(k) · Cleared
ClearedEzra Flash
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ezra Ai, Inc. · LLZ System, Image Processing, Radiological
Cleared on Apr 13, 2023 as substantially equivalent to K203182 (Subtle Medical, Inc., 2021) after a 72-day review. Its family tree reaches back 6 generations to 1992. 1 later device descends from it.
- Decided
- Apr 13, 2023
- Review
- 72 days
- Class
- Class II
- Product code
- LLZ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K922470 (1992). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 5 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 4 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 3 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 2 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 1 generation backK203182 SubtleMRSubtle Medical, Inc. · 2021
- This deviceK230264 Ezra FlashEzra Ai, Inc. · 2023
- Descendant · cites it directly · 0 of its ownK242334 Ezra FlashEzra Ai, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K242334Ezra FlashEzra Ai, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −5 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −4 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −3 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −2 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −1 | K203182 | SubtleMR | Subtle Medical, Inc. | 2021 | — |
| 0 (this device) | K230264 | Ezra Flash | Ezra Ai, Inc. | 2023 | — |
| +1 | K242334 | Ezra Flash | Ezra Ai, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in LLZ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new LLZ device
- #1 K230955 syngo Application Softwarescore 21.5 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K203182 | SubtleMRSummary page 4…21 CFR 892.2050- System, Image Processing, Radiological 1.3 Predicate Device Information Device Name SubtleMR 510(k) Number K203182 2 Device Description Ezra Flash is a Software as a Medical Device (SaMD) consisting of a software algorithm… | 2021 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K242334 | Ezra Flash | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 31 years and passes through 5 companies; a new generation was cleared every 3.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K242334 (Ezra Ai, Inc., 2025) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K203182.
How does its category compare?
All LLZ devicesLLZ System, Image Processing, Radiological: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, this device’s year, is highlighted.
FDA decisions per year · LLZ
58in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LLZ
173in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LLZ
11in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LLZ
116in 2025
MAUDE reports naming product code LLZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 76 | 36 | 20 | 152 |
| 2008 | 94 | 52 | 32 | 154 |
| 2009 | 70 | 62 | 21 | 145 |
| 2010 | 51 | 98 | 17 | 145 |
| 2011 | 106 | 79 | 30 | 454 |
| 2012 | 82 | 87 | 12 | 266 |
| 2013 | 95 | 84 | 64 | 1,130 |
| 2014 | 78 | 89 | 6 | 15,631 |
| 2015 | 64 | 90 | 16 | 211 |
| 2016 | 82 | 90 | 12 | 290 |
| 2017 | 78 | 107 | 5 | 104 |
| 2018 | 104 | 105 | 7 | 72 |
| 2019 | 74 | 107 | 2 | 88 |
| 2020 | 81 | 115 | 6 | 82 |
| 2021 | 83 | 116 | 3 | 70 |
| 2022 | 65 | 137 | 4 | 28 |
| 2023 | 87 | 157 | 8 | 26 |
| 2024 | 62 | 131 | 6 | 42 |
| 2025 | 58 | 173 | 11 | 116 |
| 2026 | 45 | 110 | 14 | — |
What is it indicated for?
Ezra Flash is an image processing software used for image enhancement of MR images. It can be used to reduce image noise in images acquired as part of non-contrast MRI exams on 3-Tesla Siemens and GE scanners for Sagittal T1, Axial T2 and Axial Flair sequences within the head region for patients > 18 years of age.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K230264 · printed Nov 6, 2026
Cite this page
510(k) Report. “K230264: Ezra Flash.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K230264
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026