FDA UDI
Not in Commercial Distribution
🇺🇸 United States
InsightRT Software Suite Server
DI: B244ISS100S0
·
Model: ISS100S
·
SIRIS MEDICAL, INC.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- InsightRT Software Suite Server
- Primary DI
- B244ISS100S0
- Version / Model
- ISS100S
- Catalog Number
- ISS100S
- Company Name
- SIRIS MEDICAL, INC.
- Labeler DUNS
- 079081812
- Distribution Status
- Not in Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-08-08
- Public Version
- 4
- Public Version Date
- 2018-08-02
- Public Version Status
- Update
- Public Device Record Key
- f5163df1-0124-4dd6-a7ec-789be6afaabb
- Distribution End Date
- 2018-08-01
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 |
|---|---|---|---|---|
| MUJ | System,Planning,Radiation Therapy Treatment | 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 | B244ISS100S0 | HIBCC |
Customer Contacts
- Phone
- 6503945161
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151560 | 000 |