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

• Primary Device ID: B3658080000
• NIH Device Record Key: fa76726e-261d-4e22-a4b8-8a84eddee62d
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: isoPoint Validation Software
• Version Model Number: 80-800
• Company DUNS: 787178920
• Company Name: Aktina Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: true
• MRI Safety Status: Labeling does not contain MRI Safety Information
• Human Cell/Tissue Product: false
• Device Kit: false
• Device Combination Product: false
• Single Use: false
• Lot Batch: true
• Serial Number: false
• Manufacturing Date: false
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: true
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B3658080000 [Primary]

FDA Product Code

• LHO: Instrument, Quality-Assurance, Radiologic

Sterilization

• Steralize Prior To Use: false
• Device Is Sterile: false

Device Entry Metadata

• Public Version Status: New
• Device Record Status: Published
• Public Version Number: 1
• Public Version Date: 2024-07-09
• Device Publish Date: 2024-07-01

Devices Manufactured by Aktina Corp.

• B3658080000 - isoPoint Validation Software: 2024-07-09Validation 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 Software: 2024-07-09 Validation software intended to be used by a Medical Physicist to accept a LINAC for clinical use by performing a Winston-Lutz t
• B36550366050 - Circular Small Field Cone Insert, Varian, 5mm: 2021-06-01
• B36550366060 - Circular Small Field Cone Insert, Varian, 6mm: 2021-06-01
• B36550366070 - Circular Small Field Cone Insert, Varian, 7mm: 2021-06-01
• B36550366080 - Circular Small Field Cone Insert, Varian, 8mm: 2021-06-01
• B36550366090 - Circular Small Field Cone Insert, Varian, 9mm: 2021-06-01
• B36550366100 - Circular Small Field Cone Insert, Varian, 10mm: 2021-06-01
• B36550366110 - Circular Small Field Cone Insert, Varian, 11mm: 2021-06-01