EZRA AI, INC.

FDA Device Registration & Listing · New York, NY, US · Registration 3027347389

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3027347389
FEI Number
3027347389
Entity Name
EZRA AI, INC.
City/State/Country
New York, NY, US
Establishment Address
287 Park Ave South, Suite 615, New York, NY 10010, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Ezra AI, Inc. (Owner Number: 10087985)
Owner / Operator Contact Address
287 Park Ave South, Suite 615, New York, NY 10010, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K242334
PMA Number
N/A

All Registered Proprietary Names

Ezra Prostate AI Ezra Plexo Ezra Flash

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2023-09-11
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-04-28

Official Correspondent

Emi Gal

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Ezra AI, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K242270 Orthofix Srl OrthoNext Platform System 2024-12-19
K261713 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.6.0) 2026-06-18
K243647 FUJIFILM Healthcare Americas Corporation Synapse PACS (7.5) 2025-06-30

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3027347389. Last updated year: 2026. Please use registration number 3027347389 when referencing this establishment in official correspondence.
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