Browse hierarchy: [Radiology (RA)](/submissions/RA) → [Subpart B — Diagnostic Devices](/submissions/RA/subpart-b%E2%80%94diagnostic-devices) → [21 CFR 892.1320](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1320) → IZD — Probe, Uptake, Nuclear

# IZD · Probe, Uptake, Nuclear

_Radiology · 21 CFR 892.1320 · Class 1_

**Canonical URL:** https://fda.innolitics.com/productcode/IZD

## Overview

- **Product Code:** IZD
- **Device Name:** Probe, Uptake, Nuclear
- **Regulation:** [21 CFR 892.1320](/submissions/RA/subpart-b%E2%80%94diagnostic-devices/892.1320)
- **Device Class:** 1
- **Review Panel:** [Radiology](/submissions/RA)

## Identification

A nuclear uptake probe is a device intended to measure the amount of radionuclide taken up by a particular organ or body region. This generic type of device may include a single or multiple detector probe, signal analysis and display equipment, patient and equipment supports, component parts, and accessories.

## Classification Rationale

Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 892.9.

## Recent Cleared Devices (20 of 30)

Showing 20 most recent of 30 cleared devices.

| Record | Device Name | Applicant | Decision Date | Decision |
| --- | --- | --- | --- | --- |
| [K133781](/device/K133781.md) | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | Apr 11, 2014 | SESE |
| [K123917](/device/K123917.md) | DECLIPSESPECT VIEWER | Surgiceye GmbH | Jan 25, 2013 | SESE |
| [K101887](/device/K101887.md) | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | Surgiceye GmbH | Mar 22, 2011 | SESE |
| [K013751](/device/K013751.md) | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | Feb 6, 2002 | SESE |
| [K983768](/device/K983768.md) | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Jul 2, 1999 | SESE |
| [K982442](/device/K982442.md) | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | Aug 25, 1998 | SESE |
| [K971167](/device/K971167.md) | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Jun 26, 1997 | SESE |
| [K961321](/device/K961321.md) | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Feb 10, 1997 | SESE |
| [K962319](/device/K962319.md) | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | Sep 13, 1996 | SESE |
| [K942580](/device/K942580.md) | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Feb 9, 1995 | SESE |
| [K932153](/device/K932153.md) | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | Sep 7, 1993 | SESE |
| [K930962](/device/K930962.md) | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | May 18, 1993 | SESE |
| [K924586](/device/K924586.md) | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | Dec 3, 1992 | SESE |
| [K922117](/device/K922117.md) | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | Oct 14, 1992 | SESE |
| [K915279](/device/K915279.md) | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | Jun 10, 1992 | SESE |
| [K921428](/device/K921428.md) | CAPTUS 500 | Capintec Instruments, Inc. | May 28, 1992 | SESE |
| [K920115](/device/K920115.md) | MEDISCINT | Oakfield Instruments, Ltd. | Mar 30, 1992 | SESE |
| [K913055](/device/K913055.md) | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Atomic Products Corp. | Sep 6, 1991 | SESE |
| [K902460](/device/K902460.md) | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | Aug 28, 1990 | SESE |
| [K896540](/device/K896540.md) | ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE | Nuclear Data Systems | Apr 19, 1990 | SESE |

## Top Applicants

- Neoprobe Corp. — 5 clearances
- Care Wise Medical Products Corp. — 4 clearances
- Capintec Instruments, Inc. — 3 clearances
- Surgiceye GmbH — 3 clearances
- Medimatic — 2 clearances

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**Source:** [https://fda.innolitics.com/productcode/IZD](https://fda.innolitics.com/productcode/IZD)

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