FDA UDI
In Commercial Distribution
🇺🇸 United States
MU2net
DI: B501MU2NET020101
·
Model: 2.1.1
·
DOSISOFT
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- MU2net
- Primary DI
- B501MU2NET020101
- Version / Model
- 2.1.1
- Catalog Number
- 2.1.1
- Company Name
- DOSISOFT
- Labeler DUNS
- 264815932
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2019-11-19
- Public Version
- 1
- Public Version Date
- 2019-11-27
- Public Version Status
- New
- Public Device Record Key
- 5a8b9193-8663-4fad-bf20-e4b79c3f6743
Device Description
MU2net is a standalone software device designed to perform secondary monitor unit (MU) or dose calculation based on DICOM RT Plan data sets provided by Radiotherapy Treatment Planning Systems.
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
- No
- Has Lot/Batch Number
- No
- Has Manufacturing Date
- No
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 40887 | Radiation therapy software | An application software program intended to facilitate/support the delivery of therapeutic radiation by enabling computer-assisted functionality in one or more of the following areas: treatment planning, simulation, record/verify, beam block CAD/CAM, quality assurance, and patient positioning. Some types may be combined with specific hardware or firmware accessories or configurations in order to function as intended. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | B501MU2NET020101 | HIBCC |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191944 | 000 |