Paddle

GUDID B365605250

Aktina Corp.

Indexed-immobilization patient positioning system

• Primary Device ID: B365605250
• NIH Device Record Key: 1e7c98c9-4f56-4bc6-a947-e759e8d5ec8f
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Paddle
• Version Model Number: 60-525
• Company DUNS: 787178920
• Company Name: Aktina Corp.
• Device Count: 1
• DM Exempt: false
• Pre-market Exempt: false
• 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: true
• Expiration Date: false
• Donation Id Number: false
• Contains Natural Rubber Latex: false
• Labeled No Natural Rubber Latex: false
• RX Perscription: false
• OTC Over-The-Counter: false

Device Identifiers

Device Issuing Agency	Device ID
HIBCC	B365605250 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

• Premarket Notification: K103616

FDA Product Code

• IYE: Accelerator, Linear, Medical

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: 2021-05-31
• Device Publish Date: 2021-05-21

Devices Manufactured by Aktina Corp.

• 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