NDS Surgical Imaging, LLC
Sarasota, FL, US
NDS SURGICAL IMAGING, LLC. appears in FDA device records in Sarasota, FL. FDA records list 10 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 10 510(k) clearances for NDS Surgical Imaging, LLC between 2008 and 2022. The busiest year on record is 2014, with 2. The most recent is 2022, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2008 | 1 |
| 2010 | 1 |
| 2012 | 1 |
| 2013 | 1 |
| 2014 | 2 |
| 2015 | 1 |
| 2016 | 1 |
| 2017 | 1 |
| 2022 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K222890 | RADIANCE ULTRA 32 4K ZEROWIRE DUO | GCJ | Substantially Equivalent | |
| K170598 | ZeroWire Mobile | GCJ | Substantially Equivalent | |
| K161228 | Radiance Ultra Series ZeroWire Embedded | GCJ | Substantially Equivalent | |
| K151609 | ZeroWire Duo Wireless HD Video Transfer System G2 or ZeroWire G2 | GCJ | Substantially Equivalent | |
| K133609 | THE DOME S6C | LLZ | Substantially Equivalent | |
| K132770 | DOME S10 | LLZ | Substantially Equivalent | |
| K131115 | ZEROWIRE DUO WIRELESS HD VIDEO TRANSFER SYSTEM, OR ZERO WIRE | GCJ | Substantially Equivalent | |
| K120709 | THE DOME GX4MP COLOR NONITOR | LLZ | Substantially Equivalent | |
| 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 | |
| K080320 | PRIMEVUE 21 3MP COLOR DISPLAY, MODEL AC-QX21-A9300 | LLZ | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2954921 | 3003301977 | NDS SURGICAL IMAGING, LLC. | 100 Paramount Drive,, Sarasota, FL 34232 US | 2026 | |
| 3014991167 | 3014991167 | NDS Surgical Imaging, LLC | Alte Poststrabe 11, Ludwigsstadt Bavaria 96337 DE | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain