Circular Small Field Cone Insert, Varian, 22mm

GUDID B36550366220

Aktina Corp.

Fixed-aperture therapeutic x-ray system collimator
Primary Device IDB36550366220
NIH Device Record Key40ab0ec0-2a41-4d51-a7da-e70f30926c1d
Commercial Distribution StatusIn Commercial Distribution
Brand NameCircular Small Field Cone Insert, Varian, 22mm
Version Model Number50-366-22
Company DUNS787178920
Company NameAktina Corp.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datefalse
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCB36550366220 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-06-01
Device Publish Date2021-05-24

Devices Manufactured by Aktina Corp.

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
B36550366050 - Circular Small Field Cone Insert, Varian, 5mm2021-06-01
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

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.