Data / Medical devices / Israel / Philips Medical Systems Technologies Ltd
Philips Medical Systems Technologies Ltd: FDA-registered device maker in Ramat Gan Tel Aviv, Israel, 12 510(k) clearances
Philips Medical Systems Technologies Ltd is registered with the FDA (registration 3010656400) in Ramat Gan Tel Aviv, Israel. It lists 2 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 17, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3010656400
- Address
- HaChilazon 5 st. Floor 1, Ramat Gan Tel Aviv, Israel, 5252269
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- August 15, 2025
- Registered through
- 2026
- Brand names listed
- LVivo EF, LVivo IQS, LVivo Seamless, LVivo Software Application, LVivo View Selection
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Automated Radiological Image Processing Software | QIH | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 17, 2025 | K243862 | LVivo Software Application | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| March 6, 2025 | K243331 | LVivo Seamless | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| March 3, 2025 | K243235 | LVivo Software Application | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| October 4, 2024 | K240553 | LVivo Software Application | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| May 24, 2024 | K240769 | LVivo IQS | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| February 1, 2023 | K222970 | LVivo IQS | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| December 9, 2021 | K212466 | LVivo Seamless | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| February 5, 2021 | K210053 | LVivo Software Application | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| September 29, 2020 | K202546 | LVivo Seamless | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| June 23, 2020 | K200232 | LVivo Software Application | QIH | Substantially Equivalent | Dia Imaging Analysis, Ltd. | accessdata.fda.gov |
| July 28, 2016 | K161382 | LVivo Software Application | LLZ | Substantially Equivalent | Diacardio, Ltd. | accessdata.fda.gov |
| August 15, 2013 | K130779 | LVIVO EF SYSTEM | LLZ | Substantially Equivalent | Diacardio, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Automated Radiological Image Processing Software
Updated March 17, 2025. 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.