FDA Product Code
FDA Product Code IZD — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Radiology
- 21 CFR Citation
- 892.1320
510(k) Clearances — 30 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K133781 | DECLIPSESPECT LAPAROSCOPY | Surgiceye GmbH | 2014-04-11 | Traditional | PDF ↗ |
| K123917 | DECLIPSESPECT VIEWER | Surgiceye GmbH | 2013-01-25 | Special | PDF ↗ |
| K101887 | CONFIDENT SURGERY SUITE 300, MODEL CSS300 | Surgiceye GmbH | 2011-03-22 | Traditional | PDF ↗ |
| K013751 | HANDHELD GAMMA FINDER (HGF) | Silicon Instruments Gmhb | 2002-02-06 | Traditional | PDF ↗ |
| K983768 | MODIFICATION TO GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1999-07-02 | Traditional | PDF ↗ |
| K982442 | C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) | Care Wise Medical Products Corp. | 1998-08-25 | Traditional | PDF ↗ |
| K971167 | NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1997-06-26 | Traditional | PDF ↗ |
| K961321 | GAMMA GUIDANCE SYSTEM | Radiation Monitoring Devices, Inc. | 1997-02-10 | Traditional | PDF ↗ |
| K962319 | NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES | Neoprobe Corp. | 1996-09-13 | Traditional | PDF ↗ |
| K942580 | NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES | Neoprobe Corp. | 1995-02-09 | Traditional | PDF ↗ |
| K932153 | THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME | Biodan Medical Systems, Ltd. | 1993-09-07 | Traditional | PDF ↗ |
| K930962 | CAPTUS 2000 WEL COUNTER | Capintec Instruments, Inc. | 1993-05-18 | Traditional | PDF ↗ |
| K924586 | CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE | Capintec Instruments, Inc. | 1992-12-03 | Traditional | PDF ↗ |
| K922117 | C-TRAK BIOPSY SYSTEM | Care Wise Medical Products Corp. | 1992-10-14 | Traditional | PDF ↗ |
| K915279 | NEOPROBE PORTABLE RADIOSCOPE DETECTOR | Neoprobe Corp. | 1992-06-10 | Traditional | PDF ↗ |
| K921428 | CAPTUS 500 | Capintec Instruments, Inc. | 1992-05-28 | Traditional | PDF ↗ |
| K920115 | MEDISCINT | Oakfield Instruments, Ltd. | 1992-03-30 | Traditional | PDF ↗ |
| K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | Atomic Products Corp. | 1991-09-06 | Traditional | PDF ↗ |
| K902460 | CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) | Oakfield Instruments, Ltd. | 1990-08-28 | Traditional | PDF ↗ |
| K896540 | ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE | Nuclear Data Systems | 1990-04-19 | Traditional | PDF ↗ |
| K896588 | ONCOPROBE II SYSTEM | Care Wise Medical Products Corp. | 1990-03-14 | Traditional | PDF ↗ |
| K891466 | ACCUSPEC THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1989-06-06 | Traditional | PDF ↗ |
| K884770 | ONCOPROBE SYSTEM | Care Wise Medical Products Corp. | 1989-01-04 | Traditional | PDF ↗ |
| K864263 | NEOPROBE PORTABLE RADIOISOTOPE DETECTOR | Neoprobe Corp. | 1986-12-29 | Traditional | PDF ↗ |
| K841440 | ND62T THYROID UPTAKE SYSTEM | Nuclear Data, Inc. | 1984-06-05 | Traditional | PDF ↗ |
| K833140 | THYROID UPTAKE SYSTEM | Advanced Medical Research Corp. | 1983-12-08 | Traditional | PDF ↗ |
| K810006 | TOMOMATIC 64 | Medimatic | 1981-02-02 | Traditional | PDF ↗ |
| K781742 | INHAMATIC 33 | Medimatic | 1978-12-04 | Traditional | PDF ↗ |
| K771301 | DIGITAL RADIATION DETECTOR | Actus, Inc. | 1977-08-04 | Traditional | PDF ↗ |
| K760595 | CARDIAC PROBE | G.D. Searle and Co. | 1976-09-17 | Traditional | PDF ↗ |
Product code IZD · Class I · Radiology. Data: openFDA.