FDA UDI
In Commercial Distribution
🇺🇸 United States
Delta4 Discover
DI: 17350005180062
·
Model: SDOS105-01
·
Scandidos AB
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Delta4 Discover
- Primary DI
- 17350005180062
- Version / Model
- SDOS105-01
- Catalog Number
- SDOS105-01 (Varian)
- Company Name
- Scandidos AB
- Labeler DUNS
- 507639297
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-25
- Public Version
- 3
- Public Version Date
- 2018-07-06
- Public Version Status
- Update
- Public Device Record Key
- 181a180f-c239-47fe-9373-08257cd53a80
Device Description
The intended use of the device is • quality assurance of patient specific treatment delivery during and before external radiotherapy treatment, including IMRT, VMAT and 4DRT (respiratory gating and tumour tracking) • quality assurance of the radiation delivery system.
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
- 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 |
|---|---|---|---|---|
| IYE | Accelerator, Linear, Medical | Radiology | 892.5050 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 38399 | Accelerator system quality assurance device | An instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 17350005180062 | GS1 |
Customer Contacts
- Phone
- +46184723030
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K151426 | 000 |