FDA.reportPublic FDA data

LUNA 3D

Primary DI
04260590372673
Brand
LUNA 3D
Company
L A P GMBH LASER APPLIKATIONEN
Model
LUNA 3D Central Server Software
Catalog number
0018440
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
04260590372673PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
04260590372673042605903726734260590372673

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
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
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
00850065937007eMotusEMPNIA INC.IYE2026-09-21
00850065937014eMotusEMPNIA INC.IYE2026-09-21
00850065937021eMotusEMPNIA INC.IYE2026-09-21
00850065937038eMotusEMPNIA INC.IYE2026-09-21
00850065937045eMotusEMPNIA INC.IYE2026-09-21
00850065937052eMotusEMPNIA INC.IYE2026-09-21
00850065937069eMotusEMPNIA INC.IYE2026-09-21
00850065937076eMotusEMPNIA INC.IYE2026-09-21
00850065937083eMotusEMPNIA INC.IYE2026-09-21
00850065937090eMotusEMPNIA INC.IYE2026-09-21
00850065937106eMotusEMPNIA INC.IYE2026-09-21
00850065937113eMotusEMPNIA INC.IYE2026-09-21
00850065937120eMotusEMPNIA INC.IYE2026-09-21
00850065937137eMotusEMPNIA INC.IYE2026-09-21
00850065937144eMotusEMPNIA INC.IYE2026-09-21
00850065937151eMotusEMPNIA INC.IYE2026-09-21
00850065937168eMotusEMPNIA INC.IYE2026-09-21
00850065937175eMotusEMPNIA INC.IYE2026-09-21
00850065937182eMotusEMPNIA INC.IYE2026-09-21
00850065937199eMotusEMPNIA INC.IYE2026-09-21
00850065937205eMotusEMPNIA INC.IYE2026-09-21
00850065937212eMotusEMPNIA INC.IYE2026-09-21
00850065937229eMotusEMPNIA INC.IYE2026-09-21
00850065937236eMotusEMPNIA INC.IYE2026-09-21
00850065937243eMotusEMPNIA INC.IYE2026-09-21
00850065937250eMotusEMPNIA INC.IYE2026-09-21
00850065937267eMotusEMPNIA INC.IYE2026-09-21
00850065937274eMotusEMPNIA INC.IYE2026-09-21
00850065937298eMotusEMPNIA INC.IYE2026-09-21
00850065937304eMotusEMPNIA INC.IYE2026-09-21