FDA.reportPublic FDA data

MOBETRON

Primary DI
00861396000308
Brand
MOBETRON
Company
INTRAOP MEDICAL CORPORATION
Model
MOBETRON
Device description
The MOBETRON is intended for use as an Electron Beam source inside an Operating Room for Electron Beam IORT. Electron beam IORT (Intra-Operative Radiation Therapy) is the use of electron radiation during surgery to treat both malignant and benign tumors. The Mobetron is not intended for unrestricted beam production. Extensive beam testing should be done in a stray radiation shielded room or a strictly controlled area. MOBETRON S/N: 72
Published
2018-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHNSystem, Radiation Therapy, Charged-Particle, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHNSystem, Radiation Therapy, Charged-Particle, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K981112000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K981112000MOBETRONIntraop Medical, Inc.1998-07-24LHN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00861396000308PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00861396000308008613960003088613960003080861396000308

GMDN Terms#

Term, Definition table
TermDefinition
Linear accelerator systemAn assembly of devices designed to produce high-energy electrons to yield high-energy x-rays used for therapeutic applications, primarily to treat cancer. It provides a uniform radiation field of uniform intensity and predictable energy level, in a beam with well defined dimensions. The principle of operation is linear acceleration of electrons by means of electromagnetic (EM) microwaves. The output is used as a treatment beam on the patient, either directly or after passing a suitable target. The system typically includes signal analysis and display devices, patient and device supports, and software.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
14086361020anguyen@intraop.com

Regulatory Flags#

DUNS number
079168716
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00864366000148MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-05-04
00864366000117MEVION S250-FIT Proton Therapy SystemMEVION MEDICAL SYSTEMS, INC.LHN2026-04-30
00858991006194ProBeam 360 Proton Therapy System - Rotating GantryVarian Medical Systems Particle Therapy GmbH & Co. KGLHN2026-04-29
EPTWTM310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTN310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTW310220PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-15
EPTWTM310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTM310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTN310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310240SemiflexPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
EPTWTW310250PinPointPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHN2026-04-14
04560333350334PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350341PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350358PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350365PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350372PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350389PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350396PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350402PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350419PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350426PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350433PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350440PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350457PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
04560333350464PROBEATHITACHI HIGH-TECH CORPORATIONLHN2026-04-01
03760290230170SDX SystemDYN'RLHN2026-02-20
03760290230187SDX SystemDYN'RLHN2026-02-20
04560333350280PROBEATHITACHI, LTD.LHN2026-01-20