Reflexion Medical Radiotherapy System

Primary DI
00860003983805
Brand
Reflexion Medical Radiotherapy System
Company
REFLEXION MEDICAL, INC.
Model
RXM1000
Device description
The RefleXion Medical Radiotherapy System (RMRS), a hybrid imaging-therapy system, is capable ofdelivering intensity-modulated radiation therapy (IMRT), stereotactic body radiation therapy (SBRT),stereotactic radiotherapy (SRT) and stereotactic radiosurgery (SRS) utilizing an on-board kilovoltage CT(kVCT) system for patient localization and field sizes based on jaws which are 40 cm wide, with slice widthchoices of 1.0 cm and 2.0 cm to optimize patient treatment. It is also equipped with a binary multileafcollimator (MLC) used to create intensity modulated radiation fields at a source-axis distance of 85 cm. Itcan achieve a nominal dose rate of 850 cGy/min.
Published
2021-02-22
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
IYEAccelerator, Linear, Medical
MUJSystem, Planning, Radiation Therapy Treatment

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2
MUJSystem, Planning, Radiation Therapy TreatmentRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190978000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190978000RefleXion Medical Radiotherapy SystemReflexion Medical, Inc.2020-03-12IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00860003983805PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00860003983805008600039838058600039838050860003983805

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
8665094001TechSupport@reflexion.com

Regulatory Flags#

DUNS number
831659169
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00860003983812RefleXion Medical Radiotherapy SystemRXM10002023-02-21

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