Data / Medical devices / United States / Philips DS North America LLC
Philips DS North America LLC: FDA-registered device maker in Gainesville, FL, United States, 9 510(k) clearances
Philips DS North America LLC is registered with the FDA (registration 3023385454) in Gainesville, FL, United States. It lists 4 device types. The FDA files 9 510(k) clearances under its listings, the newest dated June 5, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3023385454
- Address
- 3630 SW 47th Avenue, Gainesville, FL, United States, 32608
- Owner or operator
- Philips Medical Systems International BV (1217116)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- November 19, 1992
- Registered through
- 2026
- Brand names listed
- 459801507722 Biospy Grid, Sterilized, 459801508642 Breast Grid (User-Sterilized), 784027, DynaCAD, 989603203464 MRI Needle Block 12G, 989603203474MRI Needle Block 14G, 989603203484 MRI Needle Block 18G, 989603203524 Grid Immobilization Plate, 989603203574 Pillar Immobilization Plate OBC and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Guide, Needle, Surgical | GDF | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Radiological Image Processing Software For Ablation Therapy Planning And Evaluation | QTZ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| System, Nuclear Magnetic Resonance Imaging | LNH | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| June 5, 2025 | K250800 | UroNav 4 | LLZ | Substantially Equivalent | Philips DS North America, LLC | accessdata.fda.gov |
| August 2, 2021 | K212175 | DynaCAD | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| December 27, 2019 | K193403 | UroNav System | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 9, 2019 | K192200 | DynaCAD | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| October 19, 2018 | K182561 | UroNav (Version 3.0) | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| November 16, 2015 | K153073 | UroNav (Version 2.0) | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| January 22, 2014 | K133030 | DYNACAD/PROSTATE INTERVENTIONAL (DYNALOC/PROSTATE) | LLZ | Substantially Equivalent | Invivo Corporation | accessdata.fda.gov |
| July 20, 2012 | K121517 | VERSAVUE ENTERPRISE SUITE | LLZ | Substantially Equivalent | Icad, Inc. | accessdata.fda.gov |
| October 11, 2002 | K023130 | ELOQUENCE, INTEGRATED FUNCTIONAL IMAGING SYSTEM | LNH | Substantially Equivalent | Mri Devices Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Image Processing, Radiological
- All makers of Radiological Image Processing Software For Ablation Therapy Planning And Evaluation
- All makers of Guide, Needle, Surgical
- All makers of System, Nuclear Magnetic Resonance Imaging
Updated June 5, 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.