Company ยท US
Capintec, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1978 to 2019. Name variants (Inc, Corp, punctuation) are merged.
14510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KPT | Calibrator, Dose, Radionuclide | 8 |
| IZD | Probe, Uptake, Nuclear | 4 |
| IYE | Accelerator, Linear, Medical | 2 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 2 |
| DSH | Recorder, Magnetic Tape, Medical | 1 |
| IYY | Synchronizer, Electrocardiograph, Nuclear | 1 |
| JAD | System, Therapeutic, X-Ray | 1 |
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 12, 2019 | K192199 | CRC PC Smart Chamber K1 Capintec, Inc. | KPT |
| Mar 8, 2017 | K162394 | CRC-77tHR Capintec, Inc. | KPT |
| Jun 27, 2014 | K141413 | CRC PC WITH SMART CHAMBER Capintec, Inc. | KPT |
| Aug 9, 2010 | K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW Capintec, Inc. | KPT |
| Jun 28, 2007 | K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS Capintec, Inc. | KPT |
| Nov 8, 2005 | K052595 | CRC 15ULTRA Capintec, Inc. | JAQ |
| Apr 17, 2003 | K030175 | 2 BASIC Capintec, Inc. | IYE |
| Aug 2, 2002 | K020150 | CRC-15BT Capintec, Inc. | KPT |
| Jun 11, 1999 | K982448 | CARDIOLIGHT Capintec, Inc. | DSH |
| Apr 24, 1998 | K980402 | CAPINTEC MODEL 292 ELECTROMETER Capintec, Inc. | IYE |
| Mar 30, 1995 | K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER Capintec, Inc. | JJJ |
| Feb 13, 1986 | K853737 | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) Capintec, Inc. | IYY |
| Dec 3, 1982 | K823240 | CAP-RIA 16 Capintec, Inc. | JJJ |
| Feb 13, 1978 | K780157 | RADIATION TREATMENT PLANNING SYSTEM Capintec, Inc. | JAD |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 24, 2020 | Capintec Inc Captus 4000e Thyroid Uptake System, Model Numbers 5430-30151 and 5430-30152 - Product Usage: is intended to be used by trained nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Terminated |
IZD | None listed |
| Dec 4, 2018 | Capintec Inc Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 Terminated |
IZD | None listed |
| Dec 4, 2018 | Capintec Inc Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 Terminated |
IZD | None listed |
| Sep 5, 2012 | Capintec Inc Capintec Captus 3000 Thyroid Uptake System
Nuclear uptake probe intended to be used by trained Nuclear Medicine Technologists to perform thyroid uptake procedures, which consist of the measurement o Terminated |
IZD | None listed |
| Nov 9, 2011 | Capintec Inc Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02
PET dose calibrator Terminated |
KPT | K071396 |
| Oct 28, 2010 | Capintec Inc Captus 3000 Thyroid Uptake System with Portable Stand option. Capintec item number 5430-2130, serial numbers: 91001, 91003 through 91010. Manufactured by Capintec, Inc, Pittsburgh, PA. Terminated |
KPT | None listed |