# K230264: Ezra Flash

- Pathway: 510(k) (Traditional)
- Applicant: Ezra Ai, Inc.
- Decided: Apr 13, 2023 after 72 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K922470 (1992). 6 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K203182: SubtleMR, Subtle Medical, Inc. (2021) Summary page 4.

## Most influential descendants
- K242334: Ezra Flash (2025), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K230264
Methodology: https://510kreport.com/methodology