Cranial Stereotactic Localizer Frame

GUDID B365501260

Aktina Corp.

Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame Stereotactic radiosurgical/radiotherapy arch head frame

• Primary Device ID: B365501260
• NIH Device Record Key: f337fa89-4c61-47aa-a5bd-0d7fa1c55b76
• Commercial Distribution Status: In Commercial Distribution
• Brand Name: Cranial Stereotactic Localizer Frame
• Version Model Number: 50-126
• 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	B365501260 [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.

• 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
• B36550366120 - Circular Small Field Cone Insert, Varian, 12mm: 2021-06-01