FDA.reportPublic FDA data

Mobius3D

Primary DI
00850800006050
Brand
Mobius3D
Company
VARIAN MEDICAL SYSTEMS, INC.
Model
4.1
Published
2025-05-22
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

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250099000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250099000Mobius3D (4.1)Varian Medical Systems2025-05-16IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850800006050PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850800006050008508000060508508000060500850800006050

GMDN Terms#

Term, Definition table
TermDefinition
Radiation therapy softwareAn application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
009120817
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00816389020191Applicator and Dilator for Proctoscope ø26 mmGM11014310GM110143102026-05-26
00816389020207Applicator and Dilator for Proctoscope ø30 mmGM11014410GM110144102026-05-26
00816389028098Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014110GM110141102026-05-26
00816389028104Proctoscope ø 26 mmGM11014120GM110141202026-05-26
00816389028111Dilator for Proctoscope ø 26 mmGM11014130GM110141302026-05-26
00816389028128Illumination Adapter for Proctoscope ø 26 mmGM11014150GM110141502026-05-26
00816389028135Fixation ScrewGM11014160GM110141602026-05-26
00816389028142MAASTRO Rectal Applicator Set, ø 30 mmGM11014200GM110142002026-05-26
00816389028159Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014210GM110142102026-05-26
00816389028166Proctoscope ø 30 mmGM11014220GM110142202026-05-26
00816389028173Dilator for Proctoscope ø 30 mmGM11014230GM110142302026-05-26
00816389028180Illumination Adapter for Proctoscope ø 30 mmGM11014250GM110142502026-05-26
00816389028999Targeting Window Applicator ø 20 mm, for Proctoscope ø 26 mmGM11014170GM110141702026-05-26
00816389029002Targeting Window Applicator ø 24 mm, for Proctoscope ø 30 mmGM11014270GM110142702026-05-26
00850800006074Vitesee5.0Vitesse 5.02024-11-01
00810563022032ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, EllipsoidalPC-2.1E2023-04-20
00810563022049ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, SphericalPC-2.1S2023-04-20
00810563022056ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, EllipsoidalPC-2.1EL2023-04-20
00810563022063ISOLIS Cryoprobe 2.1mm (14 G) ISOLIS Cryoprobe, 20cm Length, SphericalPC-2.1SL2023-04-20
00856100006196Respiratory Gating for Scanners (RGSC)2.02022-04-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
08720168163356DSPS-Prominent® SH profile set/2MACROMEDICS B.V.IYE2026-04-22
08720168163387DSPS PRO Mask Shim Set HNSMACROMEDICS B.V.IYE2026-04-22
08720168163394DSPS PRO Mask Shim Set HOMACROMEDICS B.V.IYE2026-04-22
08720168160140DSPS-Prominent® baseplate MACROMEDICS B.V.IYE2026-04-21
08720168162557DSPS-Prominent® Cradle-IMACROMEDICS B.V.IYE2026-04-21
08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
EPTWS070031Q5200VERIQAPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-17
EPTWS0700300PQASoftPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTM600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTN600230microSiliconPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15
EPTWTW600220microSilicon XPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHIYE2026-04-15