FDA Registration Active 🇺🇸 United States

MIRION TECHNOLOGIES (CAPINTEC), INC

Reg #: 2518443 · FEI: 2518443 · Expires 2026
Products
13
Proprietary Names
130
Establishment Types
1
Classifications
13

Registration Details

Registration Name
MIRION TECHNOLOGIES (CAPINTEC), INC
Registration Number
2518443
FEI Number
2518443
Status
Active
Expiry Year
2026
Initial Importer
No
Address
7 Vreeland Rd
City
Florham Park
State
NJ
ZIP
07932
Country
US

Regulatory Submissions

510(k) Number
K871868

Owner / Operator

Firm Name
Mirion Technologies, Inc.
Operator Number
10043529
Address
7 Vreeland Road
City
Florham Park
State
NJ
Postal Code
07932
Country
US

Products

Device Name Product Code
System, Rebreathing, Radionuclide IYT
Calibrator, Dose, Radionuclide KPT
Probe, Uptake, Nuclear IZD
Shield, Protective, Personnel KPY
Shield, Vial IWW
Nebulizer (Direct Patient Interface) CAF
Filter, Bacterial, Breathing-Circuit CAH
Holder, Syringe, Lead IWR
Stretcher, Wheeled FPO
System, Applicator, Radionuclide, Remote-Controlled JAQ
Table, Operating-Room, Ac-Powered FQO
Phantom, Anthropomorphic, Nuclear IYP
Phantom, Test-Pattern, Radionuclide JAR

Proprietary Names

Venti-Scan IV convenience Kit Venti-Scan IV Venti-Pak Convenience Kit for Venti-Scan VI CRC SMART CHAMBER K1 Captus 3000 Thyroid Uptake System Captus 3000 Portable Thyroid Uptake and Well System Captus 4000e Thyroid Uptake and Well Counting System Captus 3000 Portable Thyroid Uptake System Captus 4000e Thyroid Uptake System Captus 3000 Thyroid Uptake and Well System Atomlab 500 Plus Atomlab 500 Mobile Barrier, Clear Lead Nuclear Medicine Barrier Mobile Barrier, Clear Lead Full Window Mobile Barrier, Clear Lead Standard Window Mobile Barrier, Clear Lead Hourglass Window Rotund Container Illuminated Vial Shield 5 to 10 ml Lead Vial Shield with Magnetic Cap, All Models Intego Tungsten Vial Shield Tungsten Vial Shield 511 Vial Shield Pig 50 PET Vial Pig Tungsten Vial Shield with Magnetic Cap, All Models Vial Pig Lead Vial Shield AeroTech I Venti-Pak Convenience Kit Aerotech I System Aerotech I Radioaerosol Convenience Kit, small particle delivery system Aerotech I Radioaerosol Convenience Kit Gaard Lock PET 5 cc Pro-Tec Unit Dose Pig-Red 511 Dose Drawing Syringe Shield Pro Tec PET 10 cc Pro Tec PET 5 cc without glass Z PET 5 cc Pro Tec IV 5 cc 511 Dose Drawing Syringe Shield, 20cc 511 Dose Drawing Vial Shield, 5cc Pro Tec II 3 cc Pro Tec II 5 cc Beta Syringe Shield 20 cc PET Dose Drawing 5 cc Pro Tec IV 3 cc Beta Syringe Shield 1 cc Double Ended PET Pig 1 to 20 cc syringe shield Pro Tec PET 3 cc without glass Gaard Lock PET 10 cc without glass High Density Lead Glass 3 cc PET MRI 5 cc High Density Lead Glass 1 cc PET MRI 3 cc Mac S Canister Gaard Lock PET 3 cc without glass Gaard Lock PET 10 cc Syringe Transporter PET MRI 3 cc without glass PET Unit Dose Pig Pro Tec PET 10 cc without glass 511 Dose Drawing Syringe Shield, 10cc Pro Tec II 5 cc without glass PET MRI 5 cc without glass 511 C-Tec Syringe Shield Pro Tec PET 1 cc without glass Gaard Lock PET 5 cc without glass Gaard Lock PET 3 cc Pro-Tec Unit Dose Pig-Blue Beta Syringe Shield 10 cc PET Dose Drawing 3 cc Pin-Tec Syringe Shield Pro Tec PET 5 cc Tungsten Syringe Shield Pro Tec III 5 cc Pro Tec PET 5 cc HSW Pro Tec IV 10 cc Pro Tec III 1 cc High Density Lead Glass 5 cc C-Tec Syringe Shield Pro Tec III 3 cc High Density Lead Glass 10 cc Pro Tec IV 1 cc Pro Tec II 3 cc without glass Pin-Tec Beta Syringe Shield Pro Tec III 10 cc Pro Tec PET 3 cc Pro Tec III 2.5 cc Pro-Tec Unit Dose Pig-White MRI Stretcher MRI Stretcher with Fowler Positioning CRC 55t series CRC-77tHR Pain Management C-Arm Table, 230VAC Ultra Pro Ultrasound Table 230V Surgical C-Arm Table, Rectangle Top, 230 VAC Surgical C-Arm Table, Rectangle, 115 VAC 3-D Imaging C-Arm Table , 115 VAC 3D Imaging, C-Arm Table, 230 VAC Sound Pro Combination Ultrasound Table Urology C-Arm Table-800,115VAC Surgical C-arm Table, Rectangle top, 115VAC Sound Pro Combination Ultrasound Table 230V Surgical C-arm Table, Contour 115VAC Econo Ultrasound Table 230V Pain Management C-Arm Table, Rectangular Top, 115VAC Pain Management C-Arm Table, 115VAC Ultra Pro Ultrasound Table Econo Echocardiography Table 230V Surgical C-Arm Table, Rectangle, 230 VAC Echo Pro Echocardiography Table 230V Surgical C-Arm Table, Contour, 230 VAC Echo Pro Echocardiography Table EchoVasc Pro Vascular Echocardiology Table Surgical C-Arm Table, 230 VAC Brachytherapy C-Arm Table, 230 VAC Brachytherapy C-Arm Table, 115 VAC Vasc Pro Vascular Ultrasound Table Vasc Pro Vascular Ultrasound Table 230V Echo/Vasc Pro Table 230V Pain Management C-Arm Table, Rectangular Top, 230VAC Urology C-Arm-800 Table, 230 VAC Econo Echocardiography Table Econo Ultrasound Table Surgical C-Arm Table, Contour, 115 VAC Neck Phantom Bar Phantom Smart Chamber CRC PC with Smart Chamber CRC 25 series

Establishment Types

Manufacture Medical Device