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. · QIH Automated Radiological Image Processing Software
Cleared on Jan 2, 2025 as substantially equivalent to K230264 (Ezra Ai, Inc., 2023) and 1 other predicate after a 148-day review. Its family tree reaches back 7 generations to 1992.
- Decided
- Jan 2, 2025
- Review
- 148 days
- Class
- Class II
- Product code
- QIH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K922470 (1992). No later device cites it as a predicate yet.
- Root · 7 generations backK922470 Ies, Image Enhancement SystemOpen Mri, Inc. · 1992
- 6 generations backK993802 Sharpview Image Enhancement SystemContext Vision AB · 2000
- 5 generations backK024028 Sharp View Image Enhancement SystemContext Vision AB · 2003
- 4 generations backK172768 ZOOMZetta Medical Technologies, LLC · 2018
- 3 generations backK191688 SubtleMRSubtle Medical, Inc. · 2019
- 2 generations backK203182 SubtleMRSubtle Medical, Inc. · 2021
- 1 generation backK230264 Ezra FlashEzra Ai, Inc. · 2023
- This deviceK242334 Ezra FlashEzra Ai, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K922470 | Ies, Image Enhancement System | Open Mri, Inc. | 1992 | — |
| −6 | K993802 | Sharpview Image Enhancement System | Context Vision AB | 2000 | — |
| −5 | K024028 | Sharp View Image Enhancement System | Context Vision AB | 2003 | — |
| −4 | K172768 | ZOOM | Zetta Medical Technologies, LLC | 2018 | — |
| −3 | K191688 | SubtleMR | Subtle Medical, Inc. | 2019 | — |
| −2 | K203182 | SubtleMR | Subtle Medical, Inc. | 2021 | — |
| −1 | K230264 | Ezra Flash | Ezra Ai, Inc. | 2023 | — |
| 0 (this device) | K242334 | Ezra Flash | Ezra Ai, Inc. | 2025 | — |
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 QIH? 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 QIH device
- #1 K213998 cvi42 Auto Imaging Software Applicationscore 23.5 · 7 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K230264 | Ezra FlashSummary page 5…ogical 1.3 Predicate Device Information Primary Predicate Device Name Ezra Flash (Manufactured by Ezra AI, Inc.) 510(k) Number K230264 Secondary Predicate Device Name SubtleMR (Manufactured by Subtle Medical) 510(k) Number K203182… | 2023 |
| * | K203182 | SubtleMRSummary page 5…510(k) Number K230264 Secondary Predicate Device Name SubtleMR (Manufactured by Subtle Medical) 510(k) Number K203182 Page 1 of 7 2 Device De… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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 33 years and passes through 5 companies; a new generation was cleared every 2.1 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All QIH devicesQIH Automated Radiological Image Processing Software: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · QIH
94in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · QIH
150in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · QIH
1so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · QIH
4in 2025
MAUDE reports naming product code QIH, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 2 | — | 0 | 0 |
| 2020 | 11 | 145 | 0 | 0 |
| 2021 | 19 | 125 | 0 | 0 |
| 2022 | 25 | 134 | 0 | 0 |
| 2023 | 45 | 151 | 0 | 0 |
| 2024 | 64 | 141 | 0 | 2 |
| 2025 | 94 | 150 | 0 | 4 |
| 2026 | 78 | 130 | 1 | — |
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 1.5-Tesla and 3-Tesla Siemens and GE scanners for patients > 18 years of age:
• Sagittal T1, Axial T2 and Axial Flair sequences within the head region
• Axial T2, Coronal T2 within the Abdomen region
• Sagittal T2, Axial T2, Coronal T2 within the Pelvis region
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242334 · printed Nov 6, 2026
Cite this page
510(k) Report. “K242334: 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/K242334
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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