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 | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| System, Rebreathing, Radionuclide | IYT | Class 2 | Radiology | No | 2021-12-13 |
| Calibrator, Dose, Radionuclide | KPT | Class 2 | Radiology | No | 2019-10-31 |
| Probe, Uptake, Nuclear | IZD | Class 1 | Radiology | No | 2013-02-25 |
| Shield, Protective, Personnel | KPY | Class 1 | Radiology | No | 2021-12-23 |
| Shield, Vial | IWW | Class 1 | Radiology | No | 2013-02-25 |
| Nebulizer (Direct Patient Interface) | CAF | Class 2 | Anesthesiology | No | 2021-12-23 |
| Filter, Bacterial, Breathing-Circuit | CAH | Class 2 | Anesthesiology | No | 2021-12-23 |
| Holder, Syringe, Lead | IWR | Class 1 | Radiology | No | 2013-02-25 |
| Stretcher, Wheeled | FPO | Class 2 | General Hospital | No | 2021-12-02 |
| System, Applicator, Radionuclide, Remote-Controlled | JAQ | Class 2 | Radiology | No | 2013-02-25 |
| Table, Operating-Room, Ac-Powered | FQO | Class 1 | General, Plastic Surgery | No | 2021-12-02 |
| Phantom, Anthropomorphic, Nuclear | IYP | Class 1 | Radiology | No | 2013-02-25 |
| Phantom, Test-Pattern, Radionuclide | JAR | Class 1 | Radiology | No | 2021-10-05 |
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