Data / Medical devices / Israel / Philips Medical Systems Technologies Ltd.
Philips Medical Systems Technologies Ltd.: FDA-registered device maker in Raanana Central, Israel, 7 510(k) clearances
Philips Medical Systems Technologies Ltd. is registered with the FDA (registration 9681475) in Raanana Central, Israel. It lists 1 device type. The FDA files 7 510(k) clearances under its listings, the newest dated April 24, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 9681475
- FEI number
- 3006303679
- Address
- 2 Hapnina Street, P.O. Box 46, Raanana Central, Israel, 4321538
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer
- First device listed
- May 15, 2020
- Registered through
- 2026
- Brand names listed
- Desktop Diagnostic Viewer, Enterprise Viewer, Image Management, VUE PACS, Vue Motion, Vue PACS, Vue PACS (Diagnostic), Vue PACS, Vue PACS (Diagnostic) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| April 24, 2024 | K240822 | Image Management V15 | LLZ | Substantially Equivalent | Philips Medical Systems Technologies | accessdata.fda.gov |
| April 11, 2017 | K170580 | Carestream Vue PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| February 12, 2016 | K153103 | CARESTREAM Vue PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| September 21, 2015 | K151774 | CARESTREAM Vue Motion | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| February 6, 2014 | K132824 | CARESTREAM VUE PACS VERSION 11.4 CARESTREAM VUE MOTION APPLICATION | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| October 23, 2012 | K122523 | CARESTREAM VUE PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
| October 20, 2011 | K110919 | CARESTREAM PACS | LLZ | Substantially Equivalent | Carestream Health, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 24, 2024. 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.