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/submissions/RA/subpart-b%E2%80%94diagnostic-devices/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](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K133781.md) | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | Apr 11, 2014 | SESE | | [K123917](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K123917.md) | DECLIPSESPECT VIEWER | Surgiceye GmbH | Jan 25, 2013 | SESE | | [K101887](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K101887.md) | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | Surgiceye GmbH | Mar 22, 2011 | SESE | | [K013751](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K013751.md) | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | Feb 6, 2002 | SESE | | [K983768](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K983768.md) | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Jul 2, 1999 | SESE | | [K982442](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K982442.md) | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | Aug 25, 1998 | SESE | | [K971167](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K971167.md) | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Jun 26, 1997 | SESE | | [K961321](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K961321.md) | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | Feb 10, 1997 | SESE | | [K962319](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K962319.md) | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | Sep 13, 1996 | SESE | | [K942580](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K942580.md) | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | Feb 9, 1995 | SESE | | [K932153](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K932153.md) | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | Sep 7, 1993 | SESE | | [K930962](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K930962.md) | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | May 18, 1993 | SESE | | [K924586](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K924586.md) | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | Dec 3, 1992 | SESE | | [K922117](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K922117.md) | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | Oct 14, 1992 | SESE | | [K915279](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K915279.md) | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | Jun 10, 1992 | SESE | | [K921428](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K921428.md) | CAPTUS 500 | Capintec Instruments, Inc. | May 28, 1992 | SESE | | [K920115](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K920115.md) | MEDISCINT | Oakfield Instruments, Ltd. | Mar 30, 1992 | SESE | | [K913055](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K913055.md) | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Atomic Products Corp. | Sep 6, 1991 | SESE | | [K902460](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/K902460.md) | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | Aug 28, 1990 | SESE | | [K896540](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD/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 - Surgiceye GmbH — 3 clearances - Capintec Instruments, Inc. — 3 clearances - Radiation Monitoring Devices, Inc. — 2 clearances --- **Source:** [https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD](https://fda.innolitics.com/submissions/RA/subpart-b%E2%80%94diagnostic-devices/IZD) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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