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Imaging Jet System

by General Robotic Devices, Inc.

510(k) K970782

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK970782 Date13 Nov 1997ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
JAB
Device Class
Class II
Regulation
21 CFR Part 892.1660
Advisory Committee
Radiology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Imaging Jet System is a Class II fluoroscopy system that provides physicians with a three-dimensional image of an endoscope inside a patient. It is an endoscopic accessory that visualizes the shape of an endoscope within a patient's body.

The system comprises a sensor catheter, transport unit, signal processing unit, and computer. The sensor catheter contains embedded sensors and is inserted into the endoscope's biopsy channel via an automated transport unit. The device is FDA 510(k) cleared with product code JAB and K-number K970782.

Questions

AI-generated answers, 1 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Imaging Jet System used for?

    The Imaging Jet System is a Class II fluoroscopy system that provides physicians with a three-dimensional image of an endoscope inside a patient. It visualizes the shape of an endoscope within a patient's body during medical procedures.

  • What components make up the Imaging Jet System?

    The system comprises a sensor catheter, transport unit, signal processing unit, and computer. The sensor catheter contains embedded sensors and is inserted into the endoscope's biopsy channel via an automated transport unit.

  • Is the Imaging Jet System cleared for medical use?

    Yes, the device is FDA 510(k) cleared with product code JAB and K-number K970782. It was determined to be substantially equivalent to predicate devices and reviewed by the Radiology advisory committee.

  • How is the sensor catheter used in the system?

    The sensor catheter contains embedded sensors and is inserted into the endoscope's biopsy channel via an automated transport unit. This allows the system to track and visualize the endoscope's position within the patient's body in three dimensions.