Capintec Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
14
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1564-2020Class IICaptus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is inteMarch 3, 2020
Z-0550-2019Class IICaptus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077November 5, 2018
Z-0551-2019Class IICaptus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138November 5, 2018
Z-2312-2012Class IICapintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by trained NJuly 24, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K192199CRC PC Smart Chamber K1September 12, 2019
K162394CRC-77tHRMarch 8, 2017
K141413CRC PC WITH SMART CHAMBERJune 27, 2014
K101452CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TWAugust 9, 2010
K071396CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORSJune 28, 2007
K052595CRC 15ULTRANovember 8, 2005
K0301752 BASICApril 17, 2003
K020150CRC-15BTAugust 2, 2002
K982448CARDIOLIGHTJune 11, 1999
K980402CAPINTEC MODEL 292 ELECTROMETERApril 24, 1998
K946387CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTERMarch 30, 1995
K853737VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM)February 13, 1986
K823240CAP-RIA 16December 3, 1982
K780157RADIATION TREATMENT PLANNING SYSTEMFebruary 13, 1978