Skip to content

New Camera Architecture (NCA) Video Imaging System

by Karl Storz Imaging, Inc. 510(k)

Active United States

510(k) K003325

Overview

The New Camera Architecture (NCA) Video Imaging System is an endoscopic video imaging system designed as a component for use with rigid or flexible endoscopes. It provides color television imaging for procedures such as sinoscopy, bronchoscopy, gastroscopy, colonoscopy, cystoscopy, hysteroscopy, and arthroscopy. This system is classified as a Class II medical device under FDA regulations (876.1500).

The device is intended for use in clinical settings where high-quality endoscopic visualization is required. Supplied as a reusable system, it has received FDA 510(k) clearance (K003325) under the Substantially Equivalent (SESE) determination for gastroenterology and urology applications. No third-party review was required, and the system adheres to regulatory standards for endoscopic imaging components. No specific sterility or MRI safety information is provided in the data.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK003325 Date27 Apr 2001ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

Full name
Ksi's New Camera Architecture (Nca) Video Imaging System
510(k) Number
FDA Product Code
FET
Device Class
Class II
Regulation
21 CFR Part 876.1500
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Karl Storz Imaging, Inc.

See all devices from Karl Storz Imaging, Inc. →

Questions

  • What procedures is the NCA Video Imaging System designed for?

    The NCA Video Imaging System is designed for high-quality endoscopic visualization during procedures such as sinoscopy, bronchoscopy, gastroscopy, colonoscopy, cystoscopy, hysteroscopy, and arthroscopy. It is specifically cleared for use in gastroenterology and urology applications, providing reliable imaging for diagnostic and therapeutic interventions in these specialties.

  • Is the NCA Video Imaging System reusable or single-use?

    The NCA Video Imaging System is supplied as a reusable device. It is intended for repeated use in clinical settings where high-quality endoscopic imaging is required, provided it is properly cleaned, disinfected, and maintained according to manufacturer guidelines.

  • What regulatory clearance does the NCA Video Imaging System hold?

    The NCA Video Imaging System has received FDA 510(k) clearance (K003325) under the Substantially Equivalent (SESE) determination for gastroenterology and urology applications. This clearance confirms that the device meets FDA regulatory standards for endoscopic video imaging components.

  • Can the NCA Video Imaging System be used with both rigid and flexible endoscopes?

    Yes, the NCA Video Imaging System is designed as a component for use with both rigid and flexible endoscopes. Its versatility allows it to integrate seamlessly with a variety of endoscopic tools, ensuring high-quality imaging across multiple procedures.

  • What storage or maintenance requirements apply to the NCA Video Imaging System?

    As a reusable device, the NCA Video Imaging System requires proper cleaning, disinfection, and maintenance to ensure optimal performance and safety. Follow the manufacturer’s instructions for storage, including environmental conditions (e.g., temperature, humidity) and handling protocols to prevent damage or contamination.