FDA.reportPublic FDA data

THALES 3D MR SCANNER

Primary DI
04260590372369
Brand
THALES 3D MR SCANNER
Company
L A P GMBH LASER APPLIKATIONEN
Model
Carriage System 0,35T
Catalog number
0016165-0001
Published
2021-09-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Conditional

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical

Product Code Classifications#

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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200907000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200907000Thales 3D Mr ScannerLap GmbH Laser Applikationen2020-06-03IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260590372369PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260590372369042605903723694260590372369

GMDN Terms#

Term, Definition table
TermDefinition
Multi-modality therapeutic radiation phantom, test objectA device consisting of a variety of multi-modality radiation therapy phantom designs. It can consist of an object of uniform material density or a two or three-dimensional (3-D) model containing patterns of objects, materials, or openings. It is available in both fixed and variable configurations including holders for ionization chambers, dosimeters or other radiation measurement instruments. It is a quality assurance (QA) device used in the calibration of photon and electron beam emitting radiation therapy systems and the measurement of performance attributes, e.g., beam flatness, symmetry, dose depth or geometric accuracy.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
313586582
Device count
1
Serial number
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
04260590372352THALES 3D MR SCANNERThales Phantom 0,35T0016164-00012021-09-17
04260590372383THALES 3D SCANNERCarriage System Conv.0016165-00022021-09-17
04260590372680LUNA 3DLUNA Camera Pod0018365-00012024-07-26
04260590372604LUNA 3DLUNA Camera Pod00189142024-06-17
04260590372581LUNA 3DLUNA Distribution Box0018364-00082024-06-17
04260590372598LUNA 3DLUNA Distribution Box0018364-00092024-06-17
04260590372611LUNA 3DLUNA 3D Workstation Software00184382024-06-17
04260590372628LUNA 3DLUNA 3D Central Server Software00184402024-06-17
04260590372635LUNA 3DLUNA SGRT PC0018346-00022024-06-17
04260590372642LUNA 3DLUNA SGRT PC0018346-00032024-06-17
04260590372659LUNA 3DCentral Server host PC Luna 3D0018439-00012024-06-17
04260590372666LUNA 3DLUNA 3D Workstation Software00184382024-06-17
04260590372673LUNA 3DLUNA 3D Central Server Software00184402024-06-17
04260590370860EASY CUBEEASY CUBE Core Pack0014421-00012023-08-31
04260590370877EASY CUBEEASY CUBE Cylinder Pack S0014421-00022023-08-31
04260590370884EASY CUBEEASY CUBE Cylinder Pack F0014421-00032023-08-31
04260590370891EASY CUBEEASY CUBE Head/Oval Pack F0014421-00042023-08-31
04260590370907EASY CUBEEASY CUBE Body Pack S0014421-00052023-08-31
04260590370914EASY CUBEEASY CUBE Universal Pack0014421-00062023-08-31
04260590370921EASY CUBEEASY CUBE0014438-00012023-08-31

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00840510401672KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401689KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-23
00840510401665KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-21
00840510401658KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-08
00840510401627KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401634KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00840510401641KLARITY MEDICALKlarity Medical Products, LLCIYE2026-10-05
00850065937007eMotusEMPNIA INC.IYE2026-09-21
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