FDA.reportPublic FDA data

510(k) K771301

Device
DIGITAL RADIATION DETECTOR
Applicant
Actus, Inc.
510(k) number
K771301
Product code
IZD
Decision
Substantially Equivalent (SESE)
Decision date
1977-08-04
Date received
1977-07-15
Regulation
892.1320
Classification name
Probe, Uptake, Nuclear
Medical specialty
Radiology
Review panel
Radiology
Device class
1
Clearance type
Traditional
Third party reviewed
N

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

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510(k), Device, Applicant table
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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
K942580NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIESNeoprobe Corp.1995-02-09
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