Data / Medical devices / United States / NDS Surgical Imaging, LLC.
NDS Surgical Imaging, LLC.: FDA-registered device maker in Sarasota, FL, United States, 9 510(k) clearances
NDS Surgical Imaging, LLC. is registered with the FDA (registration 2954921) in Sarasota, FL, United States. It lists 5 device types. The FDA files 9 510(k) clearances under its listings, the newest dated October 19, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2954921
- FEI number
- 3003301977
- Address
- 100 Paramount Drive, Suite 101, Sarasota, FL, United States, 34232
- Owner or operator
- NDS Surgical Imaging, LLC (9045073)
- Roles
- Manufacturer, Specification developer
- 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, Specification developer | accessdata.fda.gov |
| Device, Digital Image Storage, Radiological | LMB | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Laparoscope, General & Plastic Surgery | GCJ | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Digital Image Communications, Radiological | LMD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| System, Image Processing, Radiological | LLZ | 2 | 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 |
|---|---|---|---|---|---|---|
| October 19, 2022 | K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | GCJ | Substantially Equivalent | Nds Surgical Imaging, LLC | accessdata.fda.gov |
| May 26, 2016 | K161228 | Radiance Ultra Series ZeroWire Embedded | GCJ | Substantially Equivalent | Nds Surgical Imaging, LLC | accessdata.fda.gov |
| November 6, 2015 | K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | GCJ | Substantially Equivalent | Nds Surgical Imaging, LLC | accessdata.fda.gov |
| June 7, 2013 | K131115 | ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE | GCJ | Substantially Equivalent | Nds Surgical Imaging | accessdata.fda.gov |
| April 21, 2010 | K100195 | NDS SURGICAL IMAGING, LLC FOR THE ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, MODEL WU-WX-WY (WHERE U=R OR T, W=P, X | GCJ | Substantially Equivalent | Nds Surgical Imaging | accessdata.fda.gov |
| 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 System, Image Processing, Radiological
- All makers of Laparoscope, General & Plastic Surgery
- All makers of Device, Digital Image Storage, Radiological
- All makers of System, Digital Image Communications, Radiological
- All makers of Camera, Surgical And Accessories
Updated October 19, 2022. 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.