FDA UDI
In Commercial Distribution
🇺🇸 United States
PROBEAT
DI: 04560333350341
·
Model: PROBEAT WITH MGCS
·
HITACHI HIGH-TECH CORPORATION
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- PROBEAT
- Primary DI
- 04560333350341
- Version / Model
- PROBEAT WITH MGCS
- Company Name
- HITACHI HIGH-TECH CORPORATION
- Labeler DUNS
- 964579244
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-04-01
- Public Version
- 1
- Public Version Date
- 2026-04-09
- Public Version Status
- New
- Public Device Record Key
- 9c918f5a-8f1c-4ced-a82c-c9b1d79f419c
Device Description
The PROBEAT with MGCS is a medical device designed to produce and deliver a proton beam for the treatment of patients with localized tumors and other conditions susceptible to treatment by radiation. The only difference between the PROBEAT with MGCS and the cleared PROBEAT is the addition of the MGCS that converts the scale and format of the dimensional data of the patient specific aperture and/or compensator generated by commercially available patient treatment planning/management software into the scale and format used by an industrial, computer controlled milling machine to enable the milling machine to fashion the required aperture or compensator for patient treabment.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- Yes
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| LHN | System, Radiation Therapy, Charged-Particle, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 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. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 04560333350341 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K060834 | 000 |