FDA.reportPublic FDA data

LANDAUER

Primary DI
00860003399903
Brand
LANDAUER
Company
LANDAUER, INC.
Model
microSTAR® ii Dosimetry System
Catalog number
18000-000
Device description
The LANDAUER microSTAR®ii dosimetry system includes a compact, lightweight and portable dosimeter reader that relies on Optically Stimulated Luminescence (OSL) technology for secondary verification of radiation dose for patient therapy Quality Assurance (QA).
Published
2020-02-12
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003399903PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003399903008600033999038600033999030860003399903

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

Regulatory Flags#

DUNS number
189807159
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840510401450KLARITY MEDICALKlarity Medical Products, LLCIYE2026-08-03
05056190501211AlignRT PlusVISION RT LIMITEDIYE2026-07-30
00840510401443KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-24
00840510401436KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-22
00840510401412KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
00840510401429KLARITY MEDICALKlarity Medical Products, LLCIYE2026-07-08
00840510401382KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401399KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401405KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-23
00840510401375KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-22
00840510401368KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-09
00840510401351KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-08
00841962120500Single Hand Extremity FibreplastQfixIYE2026-06-05
00841962120517Knee / Elbow Extremity FibreplastQfixIYE2026-06-05
00841962120524Foot Extremity FibreplastQfixIYE2026-06-05
00841962120531Dual Hand / Shoulder Extremity FibreplastQfixIYE2026-06-05
00841439115305MultiFix 2QfixIYE2026-06-04
00841439115312MultiFix 2 - JointGlowQfixIYE2026-06-04
00841439115329Extremity RiserQfixIYE2026-06-04
00841439115336Extremity Riser - JointGlowQfixIYE2026-06-04
00841439115343MultiFix Indexing PostQfixIYE2026-06-04
00840510401320KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401344KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-03
00840510401283KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401290KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401306KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401313KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401337KLARITY MEDICALKlarity Medical Products, LLCIYE2026-06-01
00840510401276KLARITY MEDICALKlarity Medical Products, LLCIYE2026-05-29
08057014731224LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30