FDA.reportPublic FDA data

510(k) K942580

Device
NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES
Applicant
NEOPROBE CORP.
510(k) number
K942580
Product code
IZD  
Decision
Substantially Equivalent (SESE)
Decision date
1995-02-09
Date received
1994-05-31
Regulation
892.1320
Classification name
Probe, Uptake, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
SUSAN D TIEDY-STEVENSON
Address
425 Metro Pl. N. Suite 400 Dublin OH US 43017 43017

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code IZD  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K133781DECLIPSESPECT LAPAROSCOPYSurgiceye GmbH2014-04-11
K123917DECLIPSESPECT VIEWERSurgiceye GmbH2013-01-25
K101887CONFIDENT SURGERY SUITE 300, MODEL CSS300Surgiceye GmbH2011-03-22
K013751HANDHELD GAMMA FINDER (HGF)Silicon Instruments Gmhb2002-02-06
K983768MODIFICATION TO GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.1999-07-02
K982442C-TRAK AUTOMATIC ANALYZER (NAME CHANGE FROM ONCOPROBE II TO C-TRAK)Care Wise Medical Products Corp.1998-08-25
K971167NEOPROBE MODEL 1500 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.1997-06-26
K961321GAMMA GUIDANCE SYSTEMRadiation Monitoring Devices, Inc.1997-02-10
K962319NEOPROBE 1000 GEN 1C PORTABLE RADIOISOTOPE DETECTOR & ACCESSORIESNeoprobe Corp.1996-09-13
K932153THYROID UPTAKE SYSTEM & ATOMLAB 950 MED. SPECTROMEBiodan Medical Systems, Ltd.1993-09-07
K930962CAPTUS 2000 WEL COUNTERCapintec Instruments, Inc.1993-05-18
K924586CAPTUS 500 WELL DETECTOR W/CLINICAL LABOR SOFTWARECapintec Instruments, Inc.1992-12-03
K922117C-TRAK BIOPSY SYSTEMCare Wise Medical Products Corp.1992-10-14
K915279NEOPROBE PORTABLE RADIOSCOPE DETECTORNeoprobe Corp.1992-06-10
K921428CAPTUS 500Capintec Instruments, Inc.1992-05-28

Legacy Summary#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases

FDA Review#

Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases