Hyperscint Qa Hs-QA01
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number07540161940157 | Date13 Jan 2026 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade Name
- Hyperscint Qa
- Generic Name
- Accelerator system quality assurance device
- Model / Ref / Catalog
- HS-QA01, MDP-0015
- Primary DI / UDI-DI
- 07540161940157
- FDA Product Code
- LHO
- GMDN Term
- Accelerator system quality assurance device
- Device Class
- Class I
- Regulation Number
- 892.1940
- GUDID distribution status
- In Commercial Distribution
Overview
AI-generated summary, 27 Oct 2026
The HYPERSCINT QA HS-QA01 is an instrument, quality-assurance, radiologic. It is an accelerator system quality assurance device defined as 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 purposes. This device includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.
The device is classified as Class I. It is associated with product code LHO and regulation 892.1940. The device is subject to the Radiology filing category. Special storage conditions require the device to be kept away from sunlight and radioactive sources including ionizing radiation.
Other devices from Medscint Inc.
Questions
AI-generated answers, 27 Oct 2026
What is the Hyperscint QA HS-QA01?
It is recorded under the device type "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. FDA lists it under the product name "Instrument, Quality-Assurance, Radiologic". It is recorded as Class I.
What are the product code and regulation of the Hyperscint QA HS-QA01?
FDA records the Hyperscint QA HS-QA01 under product code LHO and regulation number 892.1940.
Who makes the Hyperscint QA HS-QA01?
Medscint Inc. is the manufacturer on record for the Hyperscint QA HS-QA01.
Properties
Other properties (11)
- Sterile: No
- Single Use: No
- Implantable: No
- Contains Latex: No
- Over-the-Counter: No
- Convenience Kit: No
- Combination Product: No
- HCT/P: No
- Lot / Batch Number: No
- Expiration Date: No
- Manufacturing Date: No