FDA.reportPublic FDA data

OARtrac

Primary DI
00851546007196
Brand
OARtrac
Company
RADIADYNE, L.L.C.
Model
OT-CDU2P
Catalog number
OT-CDU2P
Device description
OARtrac Plus Clinical Detector Unit (CDU)
Published
2019-07-03
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
NZTDosimeter, Ionizing Radiation, Implanted

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
NZTDosimeter, Ionizing Radiation, ImplantedRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K182395000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K182395000OARtrac SystemRadialdyne, LLC2019-03-22NZT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
20851546007190PackageGS11In Commercial Distribution
00851546007196PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
2085154600719020851546007190
00851546007196008515460071968515460071960851546007196

GMDN Terms#

Term, Definition table
TermDefinition
MOSFET radiation therapy dosimetry systemAn assembly of devices using metal oxide semiconductor field-effect transistor (MOSFET) technology intended to be used for on-the-spot patient or anthropomorphic radiation dose verification and monitoring during radiation therapy and radiology procedures. It typically consists of several wire-connected MOSFET dosimeters, a portable battery-powered dosimeter reader, and application software; it may include wireless data exchanging technology. Applications typically include radiation oncology therapy and dosimetry, treatment plan verification for in vivo dosimetry, brachytherapy, intraoperative radiation therapy, image-guided radiation therapy, and research.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
281-759-9600sabrinamartilla@radiadyne.com

Regulatory Flags#

DUNS number
005744772
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00851546007011ImmobiLocIL-60IL-602016-09-12
00851546007028ImmobiLocIL-100IL-1002016-09-12
00851546007035ImmobiLocILG-60FILG-60F2016-09-12
00851546007042ImmobiLocILG-60F-60mlILG-60F060ml2016-09-12
00851546007059ImmobiLocILG-90FILG-90F2016-09-12
00851546007066OARtracORB-60FORB-60F2016-09-22
00851546007073OARtracOT1-PSD-2UOT1-PSD-2U2016-09-23
00851546007103IsoLocISO-100ISO-1002018-01-31
00851546007141Photon MicroPSDPSD-PE5NPSD-PE5N2018-03-23
00851546007165QC microPSDPSD-QC5NPSD-QC5N2019-06-06
00851546007219IsoLocISO-60ISO-602018-01-31
00851546007417Photon microPSDPSD-PE5NPSD-PE5N2018-05-08
00851546007516QC microPSDPSD-QE5NPSD-QE5N2018-05-08
00851546007615Electron microPSDPSD-EE5NPSD-EE5N2019-05-22
20851546007091IsoLocISO-60ISO-602018-01-31
00851546007004AlatusALA-45 Unit TrayALA-452016-09-12
00851546007080OARtracOT-CDUOT-CDU2016-09-23
00851546007097OARtracOT-PSSOT-PSS2016-09-23
00851546007158QC MicroPSDPSD-QE5NPSD-QE5N2018-03-23
00851546007714HDR microPSDPSD-HB5NPSD-HB5N2018-05-08

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00851546007165QC microPSDRADIADYNE, L.L.C.NZT2019-06-06
20851546007169QC microPSDRADIADYNE, L.L.C.NZT2019-06-06
00851546007615Electron microPSDRADIADYNE, L.L.C.NZT2019-05-22
20851546007619Electron microPSDRADIADYNE, L.L.C.NZT2019-05-22
00851546007417Photon microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007516QC microPSDRADIADYNE, L.L.C.NZT2018-05-08
20851546007435Photon microPSDRADIADYNE, L.L.C.NZT2018-05-08
20851546007534QC microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007714HDR microPSDRADIADYNE, L.L.C.NZT2018-05-08
00851546007141Photon MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
20851546007145Photon MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
00851546007158QC MicroPSDRADIADYNE, L.L.C.NZT2018-03-23
00851546007073OARtracRADIADYNE, L.L.C.NZT2016-09-23
20851546007077OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007080OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007097OARtracRADIADYNE, L.L.C.NZT2016-09-23
00851546007066OARtracRADIADYNE, L.L.C.NZT2016-09-22
20851546007060OARtracRADIADYNE, L.L.C.NZT2016-09-22