Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014938447

FEI Number

3014938447

Entity Name

AIDOC MEDICAL LTD.

City/State/Country

Tel Aviv-Yafo, IL

Establishment Address

34, Ha-Masger, Tel Aviv-Yafo 6721119, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Aidoc Medical Ltd. (Owner Number: 10058842)

Owner / Operator Contact Address

34 hamasger st, Tel-Aviv, IL-TA 6721119, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K221330

PMA Number

N/A

All Registered Proprietary Names

BriefCase-Triage for PE BriefCase BriefCase-Triage for AD BriefCase BriefCase-Quantification of Aortic Measurement (M-Aorta) BriefCase aiOS BriefCase BriefCase-Quantification MLS BriefCase BriefCase-Triage for iPE BriefCase-Triage: CARE Multi-triage CT Body BriefCase-Quantification CAC BriefCase-Triage Central PE BriefCase BriefCase BriefCase-Triage: CARE Multi-Triage CT for Pneumothorax; Pericardial effusion; Large aortic aneurysm; Shoulder fracture BriefCase-Triage BriefCase BriefCase-Triage for CSF BriefCase-Quantification of M-AbdAo BriefCase

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-07-22
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-06-03
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-11-26
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2023-02-22
LMD	System, Digital Image Communications, Radiological	Radiology	Class 1	892.2020	2021-11-02
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2023-02-22
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2023-12-18
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2022-03-31
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2025-02-25
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2026-01-12
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2026-01-12
JAK	System, X-Ray, Tomography, Computed	Radiology	Class 2	892.1750	2023-12-18
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-12-18
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2021-10-05
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2026-03-05
QFM	Radiological Computer-Assisted Prioritization Software For Lesions	Radiology	Class 2	892.2080	2026-03-05
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2024-10-21
QIH	Automated Radiological Image Processing Software	Radiology	Class 2	892.2050	2024-05-21
QAS	Radiological Computer-Assisted Triage And Notification Software	Radiology	Class 2	892.2080	2023-02-22

Official Correspondent

Amalia Schreier

US Agent Details

Arvind Kadaba Business: Aidoc Inc. Email: arvindk@aidoc.com Phone: (860) 5931983

Related Public Records

Same Entity

Aidoc Medical 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
K220709	Aidoc Medical , Ltd.	BriefCase	2022-10-07
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
K190362	Zebra Medical Vision, Ltd.	HealthPNX	2019-05-06

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.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014938447. Last updated year: 2026. Please use registration number 3014938447 when referencing this establishment in official correspondence.