Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3014991167

FEI Number

3014991167

Entity Name

NDS Surgical Imaging, LLC

City/State/Country

Ludwigsstadt Bavaria, DE

Establishment Address

Alte Poststrabe 11, Ludwigsstadt Bavaria 96337, DE

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

NDS Surgical Imaging, LLC (Owner Number: 9045073)

Owner / Operator Contact Address

Salzufer 8, --, Berlin, DE-BE 10587, DE

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

RADIANCE ULTRA 32" 4K ZEROWIRE DUO E3 S3c S3 C3, C3i E3cHB E3c ZeroWire Evolution4K C5i E5 C5 ZeroWire or ZeroWire G2 E4c ZeroWire Plus ZeroWire Ultra ZeroWire Radiance Ultra 24" ZeroWire Embedded Radiance Ultra Series ZeroWire Embedded Radiance Ultra 32" ZeroWire Embedded Radiance Ultra 55" ZeroWire Embedded Radiance Ultra 27" ZeroWire Embedded E2c E2cHB E2 S2c ND-Cam GX5MP Vital Screen LifeVue ENDOVUE RADIANCE Evolution family

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2023-01-09
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-10-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2010-07-12
LMB	Device, Digital Image Storage, Radiological	Radiology	Class 1	892.2010	2024-09-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-10-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2015-12-17
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-10-31
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2013-12-11
GCJ	Laparoscope, General & Plastic Surgery	Gastroenterology, Urology	Class 2	876.1500	2016-07-11
LLZ	System, Image Processing, Radiological	Radiology	Class 2	892.2050	2008-10-31
KQM	Camera, Surgical And Accessories	General, Plastic Surgery	Class 1	878.4160	2001-03-13

Official Correspondent

Silke Lucht

US Agent Details

Michael Reents Business: NDS SURGICAL IMAGING, LLC Email: michael.reents@novanta.com Phone: (941) 7462413

Related Public Records

Same Entity

NDS Surgical Imaging, LLC

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Other Registrations for Same Entity

Registration Number	Establishment Name	Location
2954921	NDS SURGICAL IMAGING, LLC.	Sarasota, FL, US

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K914997	Conmedcorp	ASP-IRRATOR	1992-01-07
K153773	Olympus Medical Systems Corp.	Disposal Lens Cleaning Sheath	2016-11-22
K940141	Micro-Medical Devices, Inc.	LAPARAOSCOPES ELECTRONIC WITH STERILE SHEATH	1994-05-19
K933812	Advanced Surgical, Inc.	ADVANCED SURGICAL, INC. CANNULA CLEANING DEVICE AND ACCESSORIES	1993-12-13
K254228	Karl Storz SE & CO. KG	KARL STORZ Trocars with Valve Seals	2026-05-11

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0027-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0398 Contains: (2) C0Q04, 5x100mm Threaded Kii Access System (1) C0604, 15x100mm Non-Threaded Separator System w/Universal Seal, for laparoscopic procedures.
Z-0028-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Banding Kit, REF: K0406 Contains: (1) C0658, 11x100mm Threaded Shielded Trocar w/Universal Seal (1) C0522, 5x100mm Threaded Premium Flat Blade (1) C2202, 150mm Insufflation needle (1) C0605, 15x100mm Threaded Separator Access System (1) CB030, 5mm x 35cm Direct Drive Disposable Scissors (2) C4120, 5mm x 38cm Direct Drive Grasper Reposable Cartridge, for laparoscopic procedures.
Z-0029-2009	Applied Medical Resources Corp 22872 Avenida Empresa Rancho Santa	2	Applied Medical, Lap Roux-EN-Y Kit, REF: K2129 Contains: (1) C0Q04, 5x100mm Threaded Kii Access System (1) C0130, 12x100mm Optical Separator System, Non-handled (2) C0Q10, 5x100mm Threaded Kii Cannula and Seal (1) C0605, 15mmx100mm Threaded Cannula System, for laparoscopic procedures.
Z-0012-2022	GE Healthcare, LLC	2	Centricity Universal Viewer 7.0, Model 5829628-0XX. Radiological image processing system
Z-0023-2016	GE Healthcare	2	Centricity PACS IW by GE Healthcare Dynamic Imaging Solutions is a device that receives medical images (including mammograms) and data from various imaging sources. Images and data can be stored, communicated, processed and displayed within the system or across computer networks at distributed locations.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3014991167. Last updated year: 2026. Please use registration number 3014991167 when referencing this establishment in official correspondence.