isoPoint Validation Software

GUDID B3658080000

Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.

Aktina Corp.

Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device Accelerator system quality assurance device
Primary Device IDB3658080000
NIH Device Record Keyfa76726e-261d-4e22-a4b8-8a84eddee62d
Commercial Distribution StatusIn Commercial Distribution
Brand NameisoPoint Validation Software
Version Model Number80-800
Company DUNS787178920
Company NameAktina Corp.
Device Count1
DM Exemptfalse
Pre-market Exempttrue
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB3658080000 [Primary]

FDA Product Code

LHOInstrument, Quality-Assurance, Radiologic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-07-09
Device Publish Date2024-07-01

Devices Manufactured by Aktina Corp.

B3658080000 - isoPoint Validation Software2024-07-09Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz test.
B3658080000 - isoPoint Validation Software2024-07-09 Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz t
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B36550366060 - Circular Small Field Cone Insert, Varian, 6mm2021-06-01
B36550366070 - Circular Small Field Cone Insert, Varian, 7mm2021-06-01
B36550366080 - Circular Small Field Cone Insert, Varian, 8mm2021-06-01
B36550366090 - Circular Small Field Cone Insert, Varian, 9mm2021-06-01
B36550366100 - Circular Small Field Cone Insert, Varian, 10mm2021-06-01
B36550366110 - Circular Small Field Cone Insert, Varian, 11mm2021-06-01

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