Mirion Technologies (Capintec), Inc.
Florham Park, NJ, US
MIRION TECHNOLOGIES (CAPINTEC), INC appears in FDA device records in Florham Park, NJ. FDA records list 15 510(k) clearances between and , no PMA records and 2 registered establishments. As of , FDA records show 10 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Mirion Technologies (Capintec), Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Capintec, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Mirion Technologies (Capintec), Inc. between 1978 and 2026. The busiest year on record is 1978, with 1. The most recent is 2026, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1978 | 1 |
| 1982 | 1 |
| 1986 | 1 |
| 1995 | 1 |
| 1998 | 1 |
| 1999 | 1 |
| 2002 | 1 |
| 2003 | 1 |
| 2005 | 1 |
| 2007 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| 2017 | 1 |
| 2019 | 1 |
| 2026 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K253942 | Pulmonex II Xenon System (132-503) | IYT | Substantially Equivalent | |
| K192199 | CRC PC Smart Chamber K1 | KPT | Substantially Equivalent | |
| K162394 | CRC-77tHR | KPT | Substantially Equivalent | |
| K141413 | CRC PC WITH SMART CHAMBER | KPT | Substantially Equivalent | |
| K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | KPT | Substantially Equivalent | |
| K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | KPT | Substantially Equivalent | |
| K052595 | CRC 15ULTRA | JAQ | Substantially Equivalent | |
| K030175 | 2 BASIC | IYE | Substantially Equivalent | |
| K020150 | CRC-15BT | KPT | Substantially Equivalent | |
| K982448 | CARDIOLIGHT | DSH | Substantially Equivalent | |
| K980402 | CAPINTEC MODEL 292 ELECTROMETER | IYE | Substantially Equivalent | |
| K946387 | CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER | JJJ | Substantially Equivalent | |
| K853737 | VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) | IYY | Substantially Equivalent | |
| K823240 | CAP-RIA 16 | JJJ | Substantially Equivalent | |
| K780157 | RADIATION TREATMENT PLANNING SYSTEM | JAD | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 2518443 | 2518443 | MIRION TECHNOLOGIES (CAPINTEC), INC | 7 Vreeland Rd, Florham Park, NJ 07932 US | 2026 | and 3 more, listed in full below |
| 3042471748 | 3042471748 | Mirion Technologies (Capintec), Inc. | 800 Research Pkwy, Meriden, CT 06450 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- IYEAccelerator, Linear, Medical
- KPTCalibrator, Dose, Radionuclide
- JJJCounter (Beta, Gamma) For Clinical Use
- CAHFilter, Bacterial, Breathing-Circuit
- IWRHolder, Syringe, Lead
- CAFNebulizer (Direct Patient Interface)
- IYPPhantom, Anthropomorphic, Nuclear
- JARPhantom, Test-Pattern, Radionuclide
- IZDProbe, Uptake, Nuclear
- DSHRecorder, Magnetic Tape, Medical
- KPYShield, Protective, Personnel
- IWWShield, Vial
- FPOStretcher, Wheeled
- IYYSynchronizer, Electrocardiograph, Nuclear
- JAQSystem, Applicator, Radionuclide, Remote-Controlled
- IYTSystem, Rebreathing, Radionuclide
- JADSystem, Therapeutic, X-Ray
- FQOTable, Operating-Room, Ac-Powered
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1894-2024 | Captus 4000e Thyroid Uptake System with Well and 2 inch shielding. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. | Complaints of unexpected detachment of the collimator have been reported. | Class II | Open, Classified | |
| Z-1893-2024 | Captus 4000e Thyroid Uptake System with Well. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. | Complaints of unexpected detachment of the collimator have been reported. | Class II | Open, Classified | |
| Z-1892-2024 | Captus 4000e Thyroid Uptake System. Intended to be used to perform Thyroid Uptakes, Staff Bioassay, and wipe tests. | Complaints of unexpected detachment of the collimator have been reported. | Class II | Open, Classified | |
| Z-1069-2024 | Captus 4000e Thyroid Uptake Systems- Intended to be used by trained Nuclear Medicine Technologists or Nuclear Medicine Physicians to perform Thyroid Uptake Procedures. Models: 5430-30151, 5430-30152, and 5430-30154 | Spring arm failure with Captus 4000e Thyroid Uptake Systems, can cause the collimator to fall downward to its lowest point of travel, causing potential injury with a patient or operator | Class II | Open, Classified | |
| Z-1564-2020 | 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 Thyroid Uptake Procedures. | It is possible that the collimators have screw hole locations that were insufficiently tapped. There is a potential for the collimator assembly to fall and come into contact with a patient or operator. | Class II | Terminated | |
| Z-0551-2019 | Captus 700 Thyroid Uptake System, Model # 5430-3137 and 5430-3138 | There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground. | Class II | Terminated | |
| Z-0550-2019 | Captus 3000 Thyroid Uptake System, Model # 5430-0076 and 5430-0077 | There is a potential for the spring arm failure as a result of a broken tension rod (a component inside the arm). A break in the tension rod can casue the collimator to fall downward to its lowest point of travel, approximately 25 inches from the ground. | Class II | Terminated | |
| Z-2312-2012 | 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 of organ uptake and circulating radioactivity. | Customers who received a Capintec Captus 3000 Thyroid Uptake System with Software Revisions 1.22, 1.23, 1.24, 1.25, and 1.26 may encounter an error while using the thyroid uptake protocol ?Measure Liquid and Subtract Residual." This protocol was a new feature added to Software Revision 1.22 in January 2011. The error occurs only if the user does NOT measure the residual dose immediately after me | Class II | Terminated | |
| Z-0177-2012 | Capintec CRC 25 PET, item number 5130-3217 with Software Revisions 2.01 and 2.02 PET dose calibrator | Software error in Rev. 2.01 and Rev 2.02 for Capintec CRC 25PET | Terminated | ||
| Z-0167-2011 | 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. | The spring arm on portable stand may have been over tightened during assembly, which may result in failure. If the spring arm fails, it will not balance the collimator weight, and the arm will drop to the lowest position. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain