Atlas FDA

IZD

30 FDA 510(k) clearances · Product code

85 daysmedian time to decision
254 days90th percentile
30clearances measured

FDA profile

Official device name
Probe, Uptake, Nuclear
Device class
Class I (low risk)
Regulation
21 CFR 892.1320
Medical specialty
Radiology
Adverse events (MAUDE)
2001: 2 · 2002: 1
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
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RecordFirmDate
DECLIPSESPECT LAPAROSCOPY (K133781)Surgiceye GmbH2014-04-11
DECLIPSESPECT VIEWER (K123917)Surgiceye GmbH2013-01-25
CONFIDENT SURGERY SUITE 300, MODEL CSS300 (K101887)Surgiceye GmbH2011-03-22
HANDHELD GAMMA FINDER (HGF) (K013751)Silicon Instruments Gmhb2002-02-06
MODIFICATION TO GAMMA GUIDANCE SYSTEM (K983768)Radiation Monitoring Devices, Inc.1999-07-02
C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK) (K982442)Care Wise Medical Products Corp.1998-08-25
NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (K971167)Neoprobe Corp.1997-06-26
GAMMA GUIDANCE SYSTEM (K961321)Radiation Monitoring Devices, Inc.1997-02-10
NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIES (K962319)Neoprobe Corp.1996-09-13
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES (K942580)Neoprobe Corp.1995-02-09
THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROME (K932153)Biodan Medical Systems, Ltd.1993-09-07
CAPTUS 2000 WEL COUNTER (K930962)Capintec Instruments, Inc.1993-05-18
CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARE (K924586)Capintec Instruments, Inc.1992-12-03
C-TRAK BIOPSY SYSTEM (K922117)Care Wise Medical Products Corp.1992-10-14
NEOPROBE PORTABLE RADIOSCOPE DETECTOR (K915279)Neoprobe Corp.1992-06-10
CAPTUS 500 (K921428)Capintec Instruments, Inc.1992-05-28
MEDISCINT (K920115)Oakfield Instruments, Ltd.1992-03-30
THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 (K913055)Atomic Products Corp.1991-09-06
CARDIOSCINT (LEFT VENTRICULAR FUNCTION MONITOR) (K902460)Oakfield Instruments, Ltd.1990-08-28
ACCUSPEC THYROID UPTAKE SYSTEM SOFTWARE (K896540)Nuclear Data Systems1990-04-19
ONCOPROBE II SYSTEM (K896588)Care Wise Medical Products Corp.1990-03-14
ACCUSPEC THYROID UPTAKE SYSTEM (K891466)Nuclear Data, Inc.1989-06-06
ONCOPROBE SYSTEM (K884770)Care Wise Medical Products Corp.1989-01-04
NEOPROBE PORTABLE RADIOISOTOPE DETECTOR (K864263)Neoprobe Corp.1986-12-29
ND62T THYROID UPTAKE SYSTEM (K841440)Nuclear Data, Inc.1984-06-05
THYROID UPTAKE SYSTEM (K833140)Advanced Medical Research Corp.1983-12-08
TOMOMATIC 64 (K810006)Medimatic1981-02-02
INHAMATIC 33 (K781742)Medimatic1978-12-04
DIGITAL RADIATION DETECTOR (K771301)Actus, Inc.1977-08-04
CARDIAC PROBE (K760595)G.D. Searle and Co.1976-09-17

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Every clearance here is in the API, with alerts when new ones post.