Data / Medical devices / United States / Mirion Technologies (capintec), Inc
Mirion Technologies (capintec), Inc: FDA-registered device maker in Florham Park, NJ, United States, 8 510(k) clearances
Mirion Technologies (capintec), Inc is registered with the FDA (registration 2518443) in Florham Park, NJ, United States. It lists 13 device types. The FDA files 8 510(k) clearances under its listings, the newest dated September 12, 2019. 7 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 2518443
- Address
- 7 Vreeland Rd, Florham Park, NJ, United States, 07932
- Owner or operator
- Mirion Technologies, Inc. (10043529)
- Roles
- Manufacturer
- First device listed
- February 25, 2013
- Registered through
- 2026
- Brand names listed
- 1 to 20 cc syringe shield, 3-D Imaging C-Arm Table , 115 VAC, 3D Imaging, C-Arm Table, 230 VAC, 511 C-Tec Syringe Shield, 511 Dose Drawing Syringe Shield, 511 Dose Drawing Syringe Shield, 10cc, 511 Dose Drawing Syringe Shield, 20cc, 511 Dose Drawing Vial Shield, 5cc and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Calibrator, Dose, Radionuclide | KPT | 2 | Manufacturer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer | accessdata.fda.gov |
| Holder, Syringe, Lead | IWR | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Phantom, Anthropomorphic, Nuclear | IYP | 1 | Manufacturer | accessdata.fda.gov |
| Phantom, Test-Pattern, Radionuclide | JAR | 1 | Manufacturer | accessdata.fda.gov |
| Probe, Uptake, Nuclear | IZD | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Protective, Personnel | KPY | 1 | Manufacturer | accessdata.fda.gov |
| Shield, Vial | IWW | 1 | Manufacturer | accessdata.fda.gov |
| Stretcher, Wheeled | FPO | 2 | Manufacturer | accessdata.fda.gov |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | 2 | Manufacturer | accessdata.fda.gov |
| System, Rebreathing, Radionuclide | IYT | 2 | Manufacturer | accessdata.fda.gov |
| Table, Operating-Room, Ac-Powered | FQO | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 12, 2019 | K192199 | CRC PC Smart Chamber K1 | KPT | Substantially Equivalent | Capintec, Inc. | accessdata.fda.gov |
| March 8, 2017 | K162394 | CRC-77tHR | KPT | Substantially Equivalent | Capintec, Inc. | accessdata.fda.gov |
| June 27, 2014 | K141413 | CRC PC WITH SMART CHAMBER | KPT | Substantially Equivalent | Capintec, Inc. | accessdata.fda.gov |
| August 9, 2010 | K101452 | CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55TW | KPT | Substantially Equivalent | Capintec, Inc. | accessdata.fda.gov |
| February 19, 2009 | K090296 | ATOMLAB 400 AND ATOMLAB 500 DOSE CALIBRATORS, MODELS 086-330, -331, -332, -335 AND -336 | KPT | Substantially Equivalent | Biodex Medical Systems, Inc. | accessdata.fda.gov |
| June 28, 2007 | K071396 | CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS | KPT | Substantially Equivalent | Capintec, Inc. | accessdata.fda.gov |
| April 11, 1988 | K871868 | VENTI-SCAN II | IYT | Substantially Equivalent | Atomic Products Corp. | accessdata.fda.gov |
| January 1, 1985 | K800023 | LUNG AEROSOL UNIT | CAF | Substantially Equivalent | Cadema Medical Products, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 20, 2026 | 99677 | Class II | Ongoing | Captus 4000e Thyroid Uptake System, Models: 1. 5430-30151, 2. 5430-30152, 3. 5430-30154 | Potential for failure of the tension bolt which would allow the spring arm to unexpectedly fall to its lowest position, which is approximately 25 inches (63.5 cm) from the ground. | accessdata.fda.gov |
| April 22, 2024 | 94570 | Class II | Ongoing | 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. | accessdata.fda.gov |
| November 27, 2023 | 93824 | Class II | Ongoing | 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 | accessdata.fda.gov |
| March 3, 2020 | 85237 | Class II | Terminated | 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 Proce | 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. | accessdata.fda.gov |
| July 24, 2012 | 62982 | Class II | Terminated | 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 cir | 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 | accessdata.fda.gov |
| July 8, 2011 | 59425 | Not yet classified | Terminated | 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 | accessdata.fda.gov |
| September 20, 2010 | 56975 | Not yet classified | Terminated | 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. | accessdata.fda.gov |
Compare with other makers
- All makers of Table, Operating-Room, Ac-Powered
- All makers of Probe, Uptake, Nuclear
- All makers of Phantom, Test-Pattern, Radionuclide
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Filter, Bacterial, Breathing-Circuit
Updated September 16, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.