FDA.reportPublic FDA data

Captus 4000e Thyroid Uptake System

Primary DI
00859942006096
Brand
Captus 4000e Thyroid Uptake System
Company
Mirion Technologies (capintec), Inc.
Model
Captus 4000e Thyroid Uptake System
Catalog number
5430-30151
Device description
The Captus 4000e is a PC based Thyroid Uptake System, on a ergonomically designed mobile stand. It includes a 1024 channel MCA, automated Quality Assurance, Thyroid Uptake Module, and Bioassay module.
Published
2018-06-11
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
IZDProbe, Uptake, Nuclear

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IZDProbe, Uptake, NuclearRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859942006096PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859942006096008599420060968599420060960859942006096

GMDN Terms#

Term, Definition table
TermDefinition
Thyroid-uptake nuclear medicine systemAn assembly of diagnostic devices that comprise a non-imaging nuclear medicine system designed primarily for radioactive iodine related thyroid uptake measurement and analysis applications. It can typically be upgraded with the addition of software and hardware for use in various quality assurance (QA) or radioimmunoassay laboratory applications, e.g., wipe-test assessment or Schilling tests. It typically includes a multichannel analyser, computer, scintillation detector, detector support equipment, an operator's console, video display, well counter detector, collimator, shielding, and application software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
201-825-9500getinfo@capintec.com

Regulatory Flags#

DUNS number
047684501
Device count
1
Premarket exempt
true
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859942006287CII Transporter0670-00070670-00072019-07-01
00859942006294CII Transporter II0670-20260670-20262019-07-01
008599420063002 cc Pin-Tec Syringe Shield4300-00604300-00602019-07-01
00859942006126Capintec Syringe Shield1 cc Pin-Tec Syringe Shield4300-00342018-11-28
00859942006133Capintec Syringe Shield3 cc PIn-Tec Syringe Shield4300-00352018-11-28
00859942006140Capintec Syringe Shield5 cc Pin-Tec Syringe Shield4300-00362018-11-28
00859942006157Capintec Syringe Shield10 cc Pin-Tec Syringe Shield4300-00372018-11-28
00859942006164Capintec Syringe Shield1 cc C-Tec Syringe Shield4300-00302018-11-28
00859942006171Capintec Syringe Shield3 cc C-Tec Syringe Shield4300-00312018-11-28
00859942006188Capintec Syringe Shield5 cc C-Tec Syringe Shield4300-00322018-11-28
00859942006195Capintec Syringe Shield10 cc C-Tec Syringe Shield4300-00332018-11-28
00859942006201Capintec Syringe Shield511 C-Tec Syringe Shield, 5 cc0665-20202018-11-28
00859942006218Capintec Syringe Shield511 C-Tec Syringe Shield, 10 cc0665-20152018-11-28
00859942006225Capintec Syringe Shield511 C-Tec Syringe Shield, 20 cc0665-20212018-11-28
00859942006263Capintec T-Vial ShieldT-Vial Shield0665-00022018-11-28
00879942070750MRI Stretcher240-100240-1002023-07-31
00879942070767MRI Stretcher with Fowler Positioning240-110240-1102023-07-31
00879942070644Ultra Pro Ultrasound Table, 230V058-725058-7252023-07-21
00879942070613Sound Pro Combination Ultrasound Table, 115V058-710058-7102023-07-14
00879942070620Sound Pro Combination Ultrasound Table, 230V058-715058-7152023-07-14

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Primary DI, Brand, Company table
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B619K0020C01TA0GammaPro Laparoscopic ProbeKubtecIZD2025-03-26
B619K0021C01TH0GammaPro Angled Standard ProbeKubtecIZD2025-03-26
00841911102526neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
00841911102533neoprobeDEVICOR MEDICAL PRODUCTS, INC.IZD2024-09-16
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04260152884507Navigator 3 Wireless Probe, 14 mm Angledcrystal-photonics GmbHIZD2024-03-19
04260152884514Navigator 3 Wireless Probe Battery Packcrystal-photonics GmbHIZD2024-03-19
04260152887102Navigator 3 Control Unitcrystal-photonics GmbHIZD2024-03-19
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