Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1660](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1660) → JAB — System, X-Ray, Fluoroscopic, Non-Image-Intensified

# JAB · System, X-Ray, Fluoroscopic, Non-Image-Intensified

_Radiology · 21 CFR 892.1660 · Class 2_

**Canonical URL:** https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB

## Overview

- **Product Code:** JAB
- **Device Name:** System, X-Ray, Fluoroscopic, Non-Image-Intensified
- **Regulation:** [21 CFR 892.1660](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1660)
- **Device Class:** 2
- **Review Panel:** [Radiology](/submissions/RA)
- **3rd-party reviewable:** yes

## Identification

A non-image-intensified fluoroscopic x-ray system is a device intended to be used to visualize anatomical structures by using a fluorescent screen to convert a pattern of x-radiation into a visible image. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Classification Rationale

Class II.

## Recent Cleared Devices (2 of 2)

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K970782](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB/K970782.md) | IMAGING JET SYSTEM | General Robotic Devices, Inc. | Nov 13, 1997 | SESE |
| [K813032](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB/K813032.md) | ZIKON 100 DIGITAL X-RAY SYSTEM | Kontron Instruments, Inc. | Nov 24, 1981 | SESE |

## Top Applicants

- Kontron Instruments, Inc. — 1 clearance
- General Robotic Devices, Inc. — 1 clearance

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**Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/JAB)

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