Product code IZD
- Device name
- Probe, Uptake, Nuclear
- Medical specialty
- Radiology
- Device class
- 1
- Regulation number
- 892.1320
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K133781 | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | 2014-04-11 |
| K123917 | DECLIPSESPECT VIEWER | Surgiceye GmbH | 2013-01-25 |
| K101887 | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | Surgiceye GmbH | 2011-03-22 |
| K013751 | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | 2002-02-06 |
| K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1999-07-02 |
| K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | 1998-08-25 |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1997-06-26 |
| K961321 | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1997-02-10 |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | 1996-09-13 |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1995-02-09 |
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | 1993-09-07 |
| K930962 | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | 1993-05-18 |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | 1992-12-03 |
| K922117 | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | 1992-10-14 |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | 1992-06-10 |
| K921428 | CAPTUS 500 | Capintec Instruments, Inc. | 1992-05-28 |
| K920115 | MEDISCINT | Oakfield Instruments, Ltd. | 1992-03-30 |
| K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Atomic Products Corp. | 1991-09-06 |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | 1990-08-28 |
| K896540 | ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE | Nuclear Data Systems | 1990-04-19 |
| K896588 | ONCOPROBE II SYSTEM | Care Wise Medical Products Corp. | 1990-03-14 |
| K891466 | ACCUSPEC THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1989-06-06 |
| K884770 | ONCOPROBE SYSTEM | Care Wise Medical Products Corp. | 1989-01-04 |
| K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR | Neoprobe Corp. | 1986-12-29 |
| K841440 | ND62T THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1984-06-05 |
| K833140 | THYROID UPTAKE SYSTEM | Advanced Medical Research Corp. | 1983-12-08 |
| K810006 | TOMOMATIC 64 | Medimatic | 1981-02-02 |
| K781742 | INHAMATIC 33 | Medimatic | 1978-12-04 |
| K771301 | DIGITAL RADIATION DETECTOR | Actus, Inc. | 1977-08-04 |
| K760595 | CARDIAC PROBE | G.D. Searle and Co. | 1976-09-17 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08437018413294 | GAMMAPRO | GENERAL EQUIPMENT FOR MEDICAL IMAGING SA | 2023-01-18 |
| B939CW5APO1050 | CareWise | SOUTHERN SCIENTIFIC LIMITED | 2023-01-16 |
| B939CW5APO1060 | CareWise | SOUTHERN SCIENTIFIC LIMITED | 2023-01-16 |
| 00850014578060 | Lara Sensor, Type 6 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578121 | Lara System, 140 keV | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578114 | Lara System, 511 keV | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578107 | Lara Docking Station | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578091 | Lara QC Fixture | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578084 | Lara Sensor, Type 8 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578077 | Lara Sensor, Type 7 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578053 | Lara Sensor, Type 5 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578046 | Lara Sensor, Type 4 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578039 | Lara Sensor, Type 3 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578022 | Lara Sensor, Type 2 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578015 | Lara Sensor, Type 1 | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 00850014578008 | Lara Reader | LUCERNO DYNAMICS, LLC | 2023-01-01 |
| 03700542200360 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200353 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200346 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200339 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200322 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200315 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200308 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200292 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200285 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200278 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200261 | EUROPROBE | EURORAD | 2019-07-25 |
| 03700542200254 | EUROPROBE | EURORAD | 2019-07-25 |
| 10884521184466 | Auto Suture | Covidien LP | 2018-08-10 |
| 10884521170285 | Auto Suture | Covidien LP | 2018-08-10 |