Capintec, Inc.
Medical device manufacturer in Florham Park, NJ.
14510(k) clearances
0PMA approvals
6recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K192199 | CRC PC Smart Chamber K1KPT · Special | 09/12/2019SE |
| K162394 | CRC-77tHRKPT · Traditional | 03/08/2017SE |
| K141413 | CRC PC with Smart ChamberKPT · Special | 06/27/2014SE |
| K101452 | Capintec CRC 55T Series Dose Calibrators, Models CRC 55TR, CRC 55TPET and CRC 55TWKPT · Special | 08/09/2010SE |
| K071396 | CRC 25 Series (CRC 25R, CRC 25PET, CRC 25W) Dose CalibratorsKPT · Special | 06/28/2007SE |
| K052595 | CRC 15ULTRAJAQ · Traditional | 11/08/2005SE |
| K030175 | 2 BasicIYE · Traditional | 04/17/2003SE |
| K020150 | CRC-15BTKPT · Traditional | 08/02/2002SE |
| K982448 | CardiolightDSH · Traditional | 06/11/1999SE |
| K980402 | Capintec Model 292 ElectrometerIYE · Traditional | 04/24/1998SE |
| K946387 | Capra (Caprac-R) Wipetest and Well CounterJJJ · Traditional | 03/30/1995SE |
| K853737 | Vest(Ambulatory Ventricular Evaluating System)IYY · Traditional | 02/13/1986SE |
| K823240 | Cap-Ria 16JJJ · Traditional | 12/03/1982SE |
| K780157 | Radiation Treatment Planning SystemJAD · Traditional | 02/13/1978SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1564-2020 Class II | Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product…It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a… | 03/03/2020Terminated |
| Z-0551-2019 Class II | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the… | 11/05/2018Terminated |
| Z-0550-2019 Class II | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the… | 11/05/2018Terminated |
| Z-2312-2012 Class II | Capintec Captus 3000 Thyroid Uptake System Nuclear uptake probe intended to be used by…Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23… | 07/24/2012Terminated |
| Z-0177-2012 | Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET…Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET | 07/08/2011Terminated |
| Z-0167-2011 | Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number…The spring arm on portable stand may have been over tightened during assembly, which may result in failure.… | 09/20/2010Terminated |