Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3040335643

FEI Number

3040335643

Entity Name

AISAP LTD

City/State/Country

Ramat Gan Central, IL

Establishment Address

Sheba Road 2, Ramat Gan Central 5266202, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

AISAP LTD (Owner Number: 10093956)

Owner / Operator Contact Address

Sheba Road 2, Ramat Gan, IL-M 5262000, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K234141

PMA Number

N/A

All Registered Proprietary Names

AISAP CARDIO V1

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
POK	Computer-Assisted Diagnostic Software For Lesions Suspicious For Cancer	Radiology	Class 2	892.2060	2025-08-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2025-08-21

Official Correspondent

Margalit Anukov

US Agent Details

Yehonatan Harif Business: Yonni Email: yonni@aisap.ai Phone: (646) 6968213

Related Public Records

Same Entity

AISAP 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
K251769	Precision Medical Ventures, Inc. Dba Revealdx	RevealAI-Lung	2026-01-30
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 3040335643. Last updated year: 2026. Please use registration number 3040335643 when referencing this establishment in official correspondence.