FDA UDI
In Commercial Distribution
🇺🇸 United States
HYPERSCINT QA
DI: 07540161940010
·
Model: HS-QA01
·
Medscint Inc.
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- HYPERSCINT QA
- Primary DI
- 07540161940010
- Version / Model
- HS-QA01
- Catalog Number
- MDP-0001
- Company Name
- Medscint Inc.
- Labeler DUNS
- 204604857
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2026-01-13
- Public Version
- 1
- Public Version Date
- 2026-01-21
- Public Version Status
- New
- Public Device Record Key
- 0058e7d5-d45c-4f00-9c04-0f0d7260a59c
Device Description
HYPERSCINT QA system PRO 2CH is a plastic scintillation radiotherapy dosimeter which consists of a detector, an optical reader and a desktop standalone software. A detector is composed of channels each consisting of a water-equivalent plastic scintillator coupled to an optical cable. Dose and dose rate are obtained from each channel separately.
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
- Yes
- Has Serial Number
- Yes
- 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 |
|---|---|---|---|---|
| LHO | Instrument, Quality-Assurance, Radiologic | Radiology | 892.1940 | 1 |
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 | 07540161940010 | GS1 |
Customer Contacts
- Phone
- 8889016521
- [email protected]
Storage Conditions
- Type
- Special Storage Condition, Specify
- Special Conditions
- Keep away from sunlight and radioactive sources including ionizing radiation.