Data / Medical devices / Israel / Philips Medical Systems Technologies Ltd.
Philips Medical Systems Technologies Ltd.: FDA-registered device maker in Haifa, Israel, 24 510(k) clearances
Philips Medical Systems Technologies Ltd. is registered with the FDA (registration 3015763655) in Haifa, Israel. It lists 6 device types. The FDA files 24 510(k) clearances under its listings, the newest dated March 5, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015763655
- Address
- MATAM, Building 34, Haifa, Israel, 3100202
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- March 14, 2012
- Registered through
- 2026
- Brand names listed
- 3Mensio workstation - Picture archiving and communications system, AV Cardiac CT, AV Cardiovascular Suite, AV Vascular, AV Viewer, Advanced Visualization Workspace V15.X, Advanced Visualization Workspace V16.X, AutoQuant and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lung Computed Tomography System, Computer-Aided Detection | OEB | 2 | Exporter to the US | accessdata.fda.gov |
| Radiological Computer-Assisted Triage And Notification Software | QAS | 2 | Exporter to the US | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| System, Tomography, Computed, Emission | KPS | 2 | Exporter to the US | accessdata.fda.gov |
| System, X-Ray, Tomography, Computed | JAK | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| March 5, 2026 | K260169 | AV Cardiac CT | JAK | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| January 22, 2026 | K253735 | AV Vascular | QIH | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 28, 2025 | K251484 | CT:VQ | JAK | Substantially Equivalent | 4Dmedical Limited | accessdata.fda.gov |
| July 15, 2025 | K250181 | AV Viewer | LLZ | Substantially Equivalent | Philips Medical Systems Nederland B.V. | accessdata.fda.gov |
| August 30, 2024 | K241847 | Imbio PHA (4.0.0) | QIH | Substantially Equivalent | Imbio, Inc. | accessdata.fda.gov |
| February 1, 2024 | K232007 | CAAS MR Solutions | LLZ | Substantially Equivalent | Pie Medical Imaging BV | accessdata.fda.gov |
| November 16, 2023 | K232392 | CT Lung Ventilation Analysis Software (CT:V) | JAK | Substantially Equivalent | 4Dmedical Limited | accessdata.fda.gov |
| June 13, 2023 | K230112 | CAC Software | JAK | Substantially Equivalent | Imbio, Inc. | accessdata.fda.gov |
| April 15, 2022 | K220779 | XD | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| July 8, 2021 | K211788 | HALO | QAS | Substantially Equivalent | Nicolab B.V. | accessdata.fda.gov |
| May 14, 2020 | K193293 | XV Lung Ventilation Analysis Software | JAK | Substantially Equivalent | 4Dx Limited | accessdata.fda.gov |
| January 12, 2018 | K173588 | Illumeo System | LLZ | Substantially Equivalent | Philips Medical Systems Technologies , Ltd. | accessdata.fda.gov |
| November 3, 2017 | K172609 | CSMC Cardiac Suite | KPS | Substantially Equivalent | Cedars-Sinai Medical Center | accessdata.fda.gov |
| September 7, 2017 | K170981 | NeuroQuant | LLZ | Substantially Equivalent | Cortechs Labs, Inc. | accessdata.fda.gov |
| October 18, 2016 | K162025 | IntelliSpace Portal Platform | LLZ | Substantially Equivalent | Philips Medical Systems Nederlands B.V. | accessdata.fda.gov |
| September 9, 2016 | K161201 | ClearRead CT | OEB | Substantially Equivalent | Riverain Technologies, LLC | accessdata.fda.gov |
| May 27, 2016 | K153736 | 3mensio Workstation | LLZ | Substantially Equivalent | Pie Medical Imaging BV | accessdata.fda.gov |
| September 17, 2014 | K141069 | Lung Density Analysis | JAK | Substantially Equivalent | Imbio, LLC | accessdata.fda.gov |
| May 17, 2013 | K130451 | NEUROQ 3.6 | KPS | Substantially Equivalent | Syntermed, Inc. | accessdata.fda.gov |
| February 22, 2013 | K123646 | EMORY CARDIAC TOOLBOX 4.0 | KPS | Substantially Equivalent | Syntermed, Inc. | accessdata.fda.gov |
| May 24, 2011 | K111336 | EBW NM 2.0 | LLZ | Substantially Equivalent | Philips Medical Systems (Cleveland), Inc. | accessdata.fda.gov |
| October 4, 2010 | K102687 | MIRADA RT | LLZ | Substantially Equivalent | Mirada Medical, Ltd. | accessdata.fda.gov |
| August 4, 2010 | K101279 | CORRIDOR4DM V2010 MODEL: V2010 | LLZ | Substantially Equivalent | Invia | accessdata.fda.gov |
| August 4, 2010 | K091529 | ICAD VERALOOK CTC CAD SOFTWARE | JAK | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 10, 2024 | 95604 | Class II | Ongoing | Vue PACS Diagnostic Viewer with Vue PACS client 12.1.5 to 12.2.8.454 software Model Number: 1149418 Intended use is to provide completely scalable local and wide area PACS (Picture Archiving and Communication System) sol | A software issue affecting Philips Vue PACS may cause incorrect ischemic map and table value calculations when using the export function in the Perfusion Application for a Siemens CT perfusion study, resulting in misdiagnosis due to incorrect ischemic map and table values. | accessdata.fda.gov |
Compare with other makers
- All makers of System, X-Ray, Tomography, Computed
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
- All makers of Lung Computed Tomography System, Computer-Aided Detection
- All makers of System, Tomography, Computed, Emission
- All makers of Radiological Computer-Assisted Triage And Notification Software
Updated March 5, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.