# K242334: Ezra Flash

- Pathway: 510(k) (Traditional)
- Applicant: Ezra Ai, Inc.
- Decided: Jan 2, 2025 after 148 days
- Product code: QIH (Automated Radiological Image Processing Software)
- 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: 7 generations back to K922470 (1992). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230264: Ezra Flash, Ezra Ai, Inc. (2023) Summary page 5.
- K203182: SubtleMR, Subtle Medical, Inc. (2021) Summary page 5.

## 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 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

Source page: https://510kreport.com/device/K242334
Methodology: https://510kreport.com/methodology