IZD · Probe, Uptake, Nuclear
Radiology · 21 CFR 892.1320 · Class 1
Overview
| Product Code | IZD |
|---|---|
| Device Name | Probe, Uptake, Nuclear |
| Regulation | 21 CFR 892.1320 |
| Device Class | Class 1 |
| Review Panel | Radiology |
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 | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | Apr 11, 2014 | SESE |
| K123917 | DECLIPSESPECT VIEWER | Surgiceye GmbH | Jan 25, 2013 | SESE |
| K101887 | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | Surgiceye GmbH | Mar 22, 2011 | SESE |
| K013751 | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | Feb 6, 2002 | SESE |
| K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Jul 2, 1999 | SESE |
| K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | Aug 25, 1998 | SESE |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Jun 26, 1997 | SESE |
| K961321 | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Feb 10, 1997 | SESE |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | Sep 13, 1996 | SESE |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Feb 9, 1995 | SESE |
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | Sep 7, 1993 | SESE |
| K930962 | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | May 18, 1993 | SESE |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | Dec 3, 1992 | SESE |
| K922117 | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | Oct 14, 1992 | SESE |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | Jun 10, 1992 | SESE |
| K921428 | CAPTUS 500 | Capintec Instruments, Inc. | May 28, 1992 | SESE |
| K920115 | MEDISCINT | Oakfield Instruments, Ltd. | Mar 30, 1992 | SESE |
| K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Atomic Products Corp. | Sep 6, 1991 | SESE |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | Aug 28, 1990 | SESE |
| K896540 | 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
- Surgiceye GmbH — 3 clearances
- Capintec Instruments, Inc. — 3 clearances
- Radiation Monitoring Devices, Inc. — 2 clearances
