FDA.reportPublic FDA data

ORION System

Primary DI
03700383510048
Brand
ORION System
Company
BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.
Model
1SOPT00006
Catalog number
1SOPT00006
Device description
Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.
Published
2024-11-06
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
JAICouch, Radiation Therapy, Powered

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
JAICouch, Radiation Therapy, PoweredRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K160518000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K160518000LEONI ORION SystemLeoni Cia Cable System2016-07-14JAI

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
03700383510048PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
03700383510048037003835100483700383510048

GMDN Terms#

Term, Definition table
TermDefinition
Proton therapy system robotic patient positionerA component of a proton therapy system (PTS) designed to adjust the position of a PTS treatment table/couch or chair enabling the operator to accurately position the patient and treatment target site in relation to the proton treatment beam. The device is programmable and typically consists of mechanical supports, drive motors, and control devices. This device is a PTS beam management system (BMS) and patient positioning system (PPS) component.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
393677208
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
03700383510215ORION System1SOPT000231SOPT000232025-04-10
03700383510000ORION System1SOPT000021SOPT000022024-11-06
03700383510017ORION System1SOPT000031SOPT000032024-11-06
03700383510031ORION System1SOPT000051SOPT000052024-11-06
03700383510079ORION System1SOPT000091SOPT000092024-11-06
03700383510086ORION System1SOPT000101SOPT000102024-11-06
03700383510154ORION System1SOPT000171SOPT000172024-11-06
03700383510178ORION System1SOPT000191SOPT000192024-11-06

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00841962120388Lumen AirShuttleQfixJAI2025-12-02
00841962120395Symphony Locating Bar, PH StyleQfixJAI2025-12-02
00841962120401Portrait Head Only Mask Adapter for Access SupineQfixJAI2025-12-02
00841962120418Portrait Head & Neck Mask Adapter for Access SupineQfixJAI2025-12-02
10841962119457Symphony Locating Bar, Prodigy2™QfixJAI2025-10-23
10841962119464Symphony Locating Bar, PH StyleQfixJAI2025-10-23
00841439114841ZiFix TraverseMEDTEC, INC.JAI2025-09-12
00841962120340Edge Guide SystemQfixJAI2025-09-11
00841962119481Symphony™QfixJAI2025-07-09
00841962119498AirDrive Trolley™QfixJAI2025-07-09
00841962119504Access Arm SupportQfixJAI2025-07-09
00841962119511Access Wrist SupportQfixJAI2025-07-09
00841962119528AirShuttle Locating BarQfixJAI2025-07-09
00841962119535AirShuttle Locating BarQfixJAI2025-07-09
00841962119542AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119559InfinityLock™QfixJAI2025-07-09
00841962119573AirShuttle Transfer HandleQfixJAI2025-07-09
00841962119580InfinityLock™QfixJAI2025-07-09
00841962119597AltaQfixJAI2025-07-09
00841962119603AltaQfixJAI2025-07-09
00841962119610Locating BarQfixJAI2025-07-09
00841962119627FlexLock™QfixJAI2025-07-09
00841962119689Stradivarius™QfixJAI2025-07-09
00841962119696Encompass™QfixJAI2025-07-09
00841962119702Encompass™QfixJAI2025-07-09
00841962119719Encompass™QfixJAI2025-07-09
00841962119726AltaQfixJAI2025-07-09