AccessGUDID - DEVICE: ORION System (03700383510000)

GUDID

Device Identifier (DI) Information

Brand Name: ORION System
Version or Model: 1SOPT00002
Commercial Distribution Status: In Commercial Distribution
Catalog Number: 1SOPT00002
Company Name: BIZLINK ROBOTIC SOLUTIONS FRANCE S.A.S.

Primary DI Number: 03700383510000
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 393677208 *Terms of Use

Device Description: Electro-mechanical robotic arm for patient positioning in radiotherapy and medical imaging.

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	No
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
47236	Proton therapy system robotic patient positioner	A 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
JAI	Couch, Radiation Therapy, Powered

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K160518	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: be8e02a2-6628-4660-87e3-0bfb7e48f2a5
Public Version Date: November 14, 2024
Public Version Number: 1
DI Record Publish Date: November 06, 2024