AccessGUDID - DEVICE: PROBEAT (04560333350006)

GUDID

Device Identifier (DI) Information

Brand Name: PROBEAT
Version or Model: PROBEAT-CR
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: HITACHI, LTD.

Primary DI Number: 04560333350006
Issuing Agency: GS1
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 739444076 *Terms of Use

Device Description: The PROBEAT-CR is a proton beam irradiation system, which provides a therapeutic proton beam for clinical treatment. It is designed to deliver a proton beam with the prescribed dose, dose distribution and directed to the prescribed patient treatment site. The PROBEAT-CR is a modification to the cleared PROBEAT-V system, for installation at a different clinical site.

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):	Yes
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?
47069	Proton therapy system	An assembly of devices/sub-systems designed to produce and deliver a transverse- and longitudinal-dose proton beam to treat localized tumours and other conditions susceptible to treatment by radiation. It typically consists of components for beam production, transport and delivery; patient positioning; system and component control; and software. It will typically be configured to a particular site’s requirements.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
LHN	System, Radiation Therapy, Charged-Particle, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K191801	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: d5245a33-92ee-43c0-920d-9d1e717422b8
Public Version Date: December 05, 2022
Public Version Number: 2
DI Record Publish Date: September 24, 2019