Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3012453401

FEI Number

3012453401

Entity Name

Nano-X AI Ltd.

City/State/Country

Petah Tikva Central, IL

Establishment Address

Shlomo Shmeltzer Road 94 PO BOX 3486, ISRAEL, Petah Tikva Central 4970602, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Nano-X AI Ltd. (Owner Number: 10050295)

Owner / Operator Contact Address

Shlomo Shmeltzer Road 94, PO BOX 3486 ISRAEL, Petah Tikva, IL-M 4970602, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K190424

PMA Number

N/A

All Registered Proprietary Names

HealthFLD HealthCCSng HealthOST HealthPPT HealthICH

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2024-05-29
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2021-10-17
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2022-07-26
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2021-12-29
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2019-06-16

Official Correspondent

Miriam Nunez

US Agent Details

Michael Attias Business: Nanox AI Ltd. Email: michael.a@nanox.vision Phone: (646) 6447874

Related Public Records

Same Entity

Nano-X AI Ltd.

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
K243523	Siemens Medical Solutions USA, Inc.	NAEOTOM Alpha.Peak/ NAEOTOM Alpha; NAEOTOM Alpha.Pro; NAEOTOM Alpha.Prime	2025-02-12
K781431	General Electric Co.	ELECTRIC CT/T OPERATOR DISPLAY CONSOLE	1978-09-07
K231574	FUJIFILM Healthcare Americas Corporation	Scenaria View 4.2	2023-10-12
K233583	FUJIFILM Healthcare Americas Corporation	FCT iSTREAM Phase 1	2024-04-26
K151376	Covidien, LLC	superDimension Navigation System	2015-11-05

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0007-2011	GE Medical Systems, LLC	2	HiSpeed X/i Computed Tomography operator consoles with the Model Number 2153675 and 2247802. The expected usage of this product is to generate head and whole body CT images of human subjects.
Z-0009-2017	Philips Medical Systems	2	Brilliance 64 CT Model Number 728231 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0010-2017	Philips Medical Systems	2	Ingenuity Core Model Number 728321 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0011-2017	Philips Medical Systems	2	Ingenuity Core 128 Model Number 728323 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.
Z-0012-2017	Philips Medical Systems	2	Ingenuity CT Model Number 728326 Product Usage: Computed Tomography X-ray systems intended to product cross-sectional images of the body by computer reconstruction of X-ray transmission data taken at different angles and planes.

Similar Registrations

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3010281549	J. MORITA MFG. CORP., TOTTORI FACTORY	Kurayoshi Tottori, JP
2134213	CANON MEDICAL INFORMATICS, INC.	MINNETONKA, MN, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3012453401. Last updated year: 2026. Please use registration number 3012453401 when referencing this establishment in official correspondence.