Data / Medical devices / Germany / NDS Surgical Imaging, LLC
NDS Surgical Imaging, LLC: FDA-registered device maker in Ludwigsstadt Bavaria, Germany, 4 510(k) clearances
NDS Surgical Imaging, LLC is registered with the FDA (registration 3014991167) in Ludwigsstadt Bavaria, Germany. It lists 5 device types. The FDA files 4 510(k) clearances under its listings, the newest dated April 28, 2006. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014991167
- Address
- Alte Poststrabe 11, Ludwigsstadt Bavaria, Germany, 96337
- Owner or operator
- NDS Surgical Imaging, LLC (9045073)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- March 13, 2001
- Registered through
- 2026
- Brand names listed
- C3,, C3i, C5, C5i, ConductOR, E2, E2c, E2cHB and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Camera, Surgical And Accessories | KQM | 1 | Manufacturer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Contract manufacturer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 28, 2006 | K061018 | PLANAR DOME EX LINE MODEL DOME E2C | LLZ | Substantially Equivalent | Planar Systems, Inc. | accessdata.fda.gov |
| January 31, 2006 | K060136 | PLANAR DOME EX SERIES DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL E4C COLOR | LLZ | Substantially Equivalent | Planar Systems, Inc. | accessdata.fda.gov |
| June 16, 2004 | K040443 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM, MODEL C5I | LLZ | Substantially Equivalent | Dome Imaging Systems, Inc. | accessdata.fda.gov |
| September 11, 2003 | K032638 | DOME CX DIGITAL FLAT-PANEL DISPLAY SYSTEM MODEL, C3 COLOR AND C3 GRAY | LLZ | Substantially Equivalent | Planar Systems, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Camera, Surgical And Accessories
- All makers of System, Image Processing, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Device, Digital Image Storage, Radiological
Updated April 28, 2006. 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.