FDA.reportPublic FDA data

LUNA 3D

Primary DI
04260590372598
Brand
LUNA 3D
Company
L A P GMBH LASER APPLIKATIONEN
Model
LUNA Distribution Box
Catalog number
0018364-0009
Published
2024-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

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
K232031000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K232031000LUNA 3DLap GmbH Laser Applikationen2024-03-29IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
04260590372598PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260590372598042605903725984260590372598

GMDN Terms#

Term, Definition table
TermDefinition
Radiological video camera patient positioning/tracking systemAn assembly of hardware and software devices intended to use light-based (e.g., infrared, visible light) image acquisition to create three-dimensional (3-D) surfaces of a patient anatomy (e.g., head) to monitor patient position during diagnostic imaging, radiation treatment planning, and/or radiation therapy without the use of patient markers. It includes a camera(s), workstation, and appropriate software.

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
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
04260590370938EASY CUBEEASY CUBE Set of plates (16 x 10, 1 x 5, 2 x 2, 1 0014439-00012023-08-31

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
08720168162595Mask DSPS®-PROSH set/5MACROMEDICS B.V.IYE2026-04-23
08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162779DSPS-Prominent® Cradle-IIIMACROMEDICS B.V.IYE2026-04-22
08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
08720168162793DSPS-Prominent® Cradle-VIMACROMEDICS B.V.IYE2026-04-22
08720168162854Mask DSPS®-PROSCVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162861Mask DSPS®-PROSC set/5MACROMEDICS B.V.IYE2026-04-22
08720168162878Mask DSPS®-PROSCVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162885Mask DSPS®-PROSCL set/5MACROMEDICS B.V.IYE2026-04-22
08720168163325DSPS-Prominent® Cradle-VIIMACROMEDICS B.V.IYE2026-04-22