FDA.reportPublic FDA data

HYPERSCINT QA

Primary DI
07540161940157
Brand
HYPERSCINT QA
Company
Medscint Inc.
Model
HS-QA01
Catalog number
MDP-0015
Device description
HYPERSCINT QA reader device of the HYPERSCINT QA system PRO 2 CH.
Published
2026-01-13
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07540161940157PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07540161940157075401619401577540161940157

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn 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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight and radioactive sources including ionizing radiation.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
8889016521support@medscint.com

Regulatory Flags#

DUNS number
204604857
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
false
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07540161940010HYPERSCINT QAHS-QA01MDP-00012026-01-13
07540161940041HYPERSCINT QAHS-QA01MDP-00042026-01-13
07540161940126HYPERSCINT QAHS-QA01MDP-00122026-01-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
07540161940010HYPERSCINT QAMedscint Inc.LHO2026-01-13
07540161940041HYPERSCINT QAMedscint Inc.LHO2026-01-13
07540161940126HYPERSCINT QAMedscint Inc.LHO2026-01-13
00811376030863Adapt LTE powered by Accuray CenosAccuray IncorporatedLHO2025-12-19
G34310010261IBA QUASAR™ Programmable Respiratory Motion Phantom 2Modus Medical Devices IncLHO2025-12-17
G34310010280QUASAR Static PhantomModus Medical Devices IncLHO2025-12-17
07340201503782AQUAElekta Solutions ABLHO2025-12-10
07340201500101AQUAElekta Solutions ABLHO2025-05-15
09421904268340Volpara Live VOLPARA HEALTH TECHNOLOGIES LIMITEDLHO2025-05-06
00855141006417MaximQAVARIAN MEDICAL SYSTEMS, INC.LHO2025-03-04
00810106410807Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.LHO2025-02-13
04995047067740RadiCSEIZO CORPORATIONLHO2024-11-08
G34350033110150QUASARModus Medical Devices IncLHO2024-10-17
G34350033120150QUASARModus Medical Devices IncLHO2024-10-17
G34350033310150QUASARModus Medical Devices IncLHO2024-10-17
G34350033320150QUASARModus Medical Devices IncLHO2024-10-17
G34350036270QUASARModus Medical Devices IncLHO2024-10-17
G34350036400QUASARModus Medical Devices IncLHO2024-10-17
G34350033460QUASARModus Medical Devices IncLHO2024-07-05
B3658080000isoPoint Validation SoftwareAktina Corp.LHO2024-07-01
04547410538861FCR 1Shot Phantom PlusFUJIFILM CORPORATIONLHO2024-06-07
G34310010231000QUASARModus Medical Devices IncLHO2024-04-15
G34310010240QUASARModus Medical Devices IncLHO2024-04-15
G34350037600QUASARModus Medical Devices IncLHO2024-04-15
G34350037650QUASARModus Medical Devices IncLHO2024-04-15
G34350037700QUASARModus Medical Devices IncLHO2024-04-15
EPTWT100560OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29
EPTWT100570OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29
EPTWT100580OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29
04260590370860EASY CUBEL A P GMBH LASER APPLIKATIONENLHO2023-08-31