FDA UDI
In Commercial Distribution
🇺🇸 United States
Electron Beam Shaping Full System, Siemens 95 cm, Full System
DI: B365524850
·
Model: 52-485
·
Aktina Corp.
Product Codes
1
GMDN Terms
2
Identifiers
1
Pkg Device Count
1
Let the assistant research this device
The Research Assistant compiles product codes, classification, clearances and adverse events for this device — and cites every record.
Free to try · every answer cites its records
Basic Information
- Brand Name
- Electron Beam Shaping Full System, Siemens 95 cm, Full System
- Primary DI
- B365524850
- Version / Model
- 52-485
- Company Name
- Aktina Corp.
- Labeler DUNS
- 787178920
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-24
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 5b67828b-2460-48d0-9ca9-73da0a34a38f
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- Has Lot/Batch Number
- Yes
- 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 |
|---|---|---|---|---|
| IXI | Block, Beam-Shaping, Radiation Therapy | Radiology | 892.5710 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 37079 | Radiation therapy beam block production hot-wire | A mains electricity (AC-powered) device designed with a thin electrically-heated wire (hot-wire) that is used in the manual production of radiation therapy beam blocks (custom-made radiation collimators) which are used to configure a patient specific radiation field. The hot-wire is used to cut out the required patterns (the moulds) in a special Styrofoam material, e.g., Styrodur that will become templates used in the casting of a beam block(s). These moulds are configured from precise modelling data of the area to be treated for each individual patient thereby enabling production of exact beam blocks that control the treatment area during the radiotherapy treatment. | No | Active |
| 37215 | Radiation therapy beam block production plate | A dedicated device, a dish, used for the manual production of beam blocks which serve to configure a radiation field. This device is used in the production of radiotherapy blocks to cool down the melted metal, e.g., Rose's metal [consisting of lead (Pb), tin (Sn) and bismuth] when this has been poured into the moulds. It may also have the function of vibrating the metal during the cooling process to ensure equal distribution of the metal throughout the mould. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B365524850 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K973953 | 000 |