MIRION TECHNOLOGIES (CAPINTEC), INC

FDA Device Registration & Listing · Florham Park, NJ, US · Registration 2518443

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
2518443
FEI Number
2518443
Entity Name
MIRION TECHNOLOGIES (CAPINTEC), INC
City/State/Country
Florham Park, NJ, US
Establishment Address
7 Vreeland Rd, Florham Park, NJ 07932, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Mirion Technologies, Inc. (Owner Number: 10043529)
Owner / Operator Contact Address
7 Vreeland Road, Florham Park, NJ 07932, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
N/A
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
IYT System, Rebreathing, Radionuclide Radiology Class 2 892.1390 2021-12-13
KPT Calibrator, Dose, Radionuclide Radiology Class 2 892.1360 2019-10-31
IZD Probe, Uptake, Nuclear Radiology Class 1 892.1320 2013-02-25
KPT Calibrator, Dose, Radionuclide Radiology Class 2 892.1360 2021-11-18
KPY Shield, Protective, Personnel Radiology Class 1 892.6500 2021-12-23
IWW Shield, Vial Radiology Class 1 892.6500 2013-02-25
CAF Nebulizer (Direct Patient Interface) Anesthesiology Class 2 868.5630 2021-12-23
CAH Filter, Bacterial, Breathing-Circuit Anesthesiology Class 2 868.5260 2021-12-23
IWR Holder, Syringe, Lead Radiology Class 1 892.6500 2013-02-25
FPO Stretcher, Wheeled General Hospital Class 2 880.6910 2021-12-02
KPT Calibrator, Dose, Radionuclide Radiology Class 2 892.1360 2013-02-25
JAQ System, Applicator, Radionuclide, Remote-Controlled Radiology Class 2 892.5700 2013-02-25
KPT Calibrator, Dose, Radionuclide Radiology Class 2 892.1360 2017-03-10
FQO Table, Operating-Room, Ac-Powered General, Plastic Surgery Class 1 878.4960 2021-12-02
IYP Phantom, Anthropomorphic, Nuclear Radiology Class 1 892.1370 2013-02-25
JAR Phantom, Test-Pattern, Radionuclide Radiology Class 1 892.1420 2021-10-05

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Mirion Technologies, Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3042471748 Mirion Technologies (Capintec), Inc. Meriden, CT, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K942580 Neoprobe Corp. NEOPROBE 1000 PORTABLE RADIOISOTOPE DETECTOR AND ACCESSORIES 1995-02-09
K163485 Adherium (Nz), Ltd. SmartTouch 2017-08-30
K781467 Travenol Laboratories, S.A. U-FLOAT VALVE 2D9023 1978-09-07
K962045 Mallinckrodt Medical ANESTHESIA BREATHING CIRCUIT/ANESTHESIA BREATHING KIT 1996-11-26

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0023-05 Stryker Medical 2
Stryker brand Rugged EZ-Pro R4 Ambulance Cot, model 6092.
Z-0036-2024 Getinge Usa Sales Inc 1
Meera Mobile Operating Table-to support and position the patient immediately before, during and after surgical interventions as well as for examination and treatment. Model Number: 7200.01F2

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 2518443. Last updated year: 2026. Please use registration number 2518443 when referencing this establishment in official correspondence.
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