Philips Medical Systems Technologies
IsraelFDA applicant, unverified FDA FEI 3015763655
- Devices
- 4
- Registrations
- FDA
- FDA recalls
- 11 ongoing
At a glance
Market reach
- United States
- FDA establishment, FDA recalls
What Philips Medical Systems Technologies makes
Philips Medical Systems Technologies produces image management software, specifically the Image Management V15 system, designed for handling, storing, and distributing medical imaging data within healthcare settings.
The company’s portfolio is regulated under FDA 510(k) clearance as Class II devices, and the products are listed in the FDA’s 510(k) registry. The manufacturer is based in the United States.
Catalogue
Spectral CT Verida Family Ref K253649
Regimes: 510(k) Registry: 510(k)Spectral CT 7500 RT Ref K240844
Regimes: 510(k) Registry: 510(k)Illumeo System Ref K173588
Regimes: 510(k) Registry: 510(k)Image Management V15 Ref K240822
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3015763655
- Address
- MATAM, Building 34, Haifa
FDA recalls
FDA recall records list 1 recall initiated by Philips Medical Systems Technologies, initiated on 2024-10-10. By recorded status: 1 ongoing. The reasons filed fall into these groups: software or firmware. A recall is often a precaution started by the manufacturer, and a count of records is not a verdict on a company.
Recalls initiated per year
- 2017 0
- 2018 0
- 2019 0
- 2020 0
- 2021 0
- 2022 0
- 2023 0
- 2024 1
- 2025 0
- 2026 0
2024
- 10 Oct 2024 Z-0497-2025 Class II Ongoing 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.
Full distribution text
- 10 Oct 2024 Z-0497-2025 Class II Ongoing 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.
FDA establishments
- Philips Medical Systems Technologies Ltd. HAIFA · IL FEI 3008581796
- Philips Medical Systems Technologies Ltd Ramat Gan Tel Aviv · IL FEI 3010656400
Frequently asked questions
How many devices does Philips Medical Systems Technologies have in the registry?
The registry currently lists 4 devices for Philips Medical Systems Technologies. Devices recorded under merged duplicate company entries are counted once.
Which registries list Philips Medical Systems Technologies's devices?
Among its 4 most recently registered devices, Philips Medical Systems Technologies has devices listed in FDA 510(k) (4 devices).
What risk classes do Philips Medical Systems Technologies's devices fall under?
Among its 4 most recently registered devices, the classes recorded for Philips Medical Systems Technologies's devices are Class II. Each device page shows its own class and authorisation.
Are there FDA recall records for Philips Medical Systems Technologies?
FDA recall records list 1 recall initiated by Philips Medical Systems Technologies, the most recent initiated on 10 Oct 2024. 1 of them is recorded as ongoing. A recall is often a precaution started by the manufacturer; the records say nothing about the company's overall record.
What are the newest devices from Philips Medical Systems Technologies in the registry?
The most recently registered devices listed for Philips Medical Systems Technologies include Spectral CT Verida Family, Spectral CT 7500 RT, Illumeo System and Image Management V15.
Which FDA establishments are linked to Philips Medical Systems Technologies?
2 FDA establishments are linked to Philips Medical Systems Technologies in the registry; they are listed on the company page.