4DMEDICAL LIMITED

FDA Device Registration & Listing · Carlton Victoria, AU · Registration 3017426576

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
3017426576
FEI Number
3017426576
Entity Name
4DMEDICAL LIMITED
City/State/Country
Carlton Victoria, AU
Establishment Address
Level 7 Melbourne Connect, 700 Swanston Street, Carlton Victoria 3053, AU
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
4DMedical Limited (Owner Number: 10077775)
Owner / Operator Contact Address
Level 7,, 700 Swanston street, Carlton, AU-VIC 3053, AU
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K193293
PMA Number
N/A

All Registered Proprietary Names

PHA 4 RV/LV Software Imbio CAC Software CT Lung Ventilation Analysis Software CT:V CT LVAS CT:VQ XV LVAS XV Lung Ventilation Analysis Software System

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 2025-02-06
QIH Automated Radiological Image Processing Software Radiology Class 2 892.2050 2025-02-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-02-06
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2023-11-28
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2025-12-03
JAK System, X-Ray, Tomography, Computed Radiology Class 2 892.1750 2020-09-21

Official Correspondent

No official correspondent registered.

US Agent Details

Andreas Fouras Business: 4DMedical Email: regulatory@4dmedical.com Phone: (818) 4031151

Related Public Records

Same Entity

4DMedical Limited
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
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

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 3017426576. Last updated year: 2026. Please use registration number 3017426576 when referencing this establishment in official correspondence.
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