FDA.reportPublic FDA data

Cross-Hair Reticule, XRETIC

Primary DI
B365542250
Brand
Cross-Hair Reticule, XRETIC
Company
Aktina Corp.
Model
54-225
Published
2021-05-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information

Product Codes#

Code, Name table
CodeName
IWEMonitor, Patient Position, Light-Beam

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IWEMonitor, Patient Position, Light-BeamRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365542250PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Patient positioning patterned-light instrumentA fixed or variable focal distance unit used to project a light pattern, e.g., grid or crosshatch, that aids in the positioning of patients during diagnostic imaging, radiation therapy, or treatment planning procedures. It is intended to enable precise and reproducible 1, 2, or multi-dimensional alignment of a selected portion(s) of the patient's anatomy with respect to the radiation beam or beams used for diagnostic or therapeutic procedures. Light-based positioning units can be freestanding units or incorporated as a component to a diagnostic imaging or radiation therapy system. It typically includes: a light bulb, a grid to shape the pattern, and mechanical/electronic controls.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Premarket exempt
true
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
B365112200Head and Neck Overlay with Shoulder Restraints11-2202016-09-24
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B3658080000isoPoint Validation Software80-8002024-07-01
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B365603100Respiratory Belt with Bladder, Small60-3102016-09-28
B365603110Respiratory Belt with Bladder, Medium60-3112016-09-28
B365603120Respiratory Belt with Bladder, Large60-3122016-09-28
B365503710Transport Cart, SRS Cones50-3712021-05-21
B365503720Bar Code Reader Kit50-3722021-05-21
B365503750Film Holder50-3752021-05-21
B365503022100Circular Small Field Cone Insert, Elekta, 21mm50-302-2102016-10-04
B365503022200Circular Small Field Cone Insert, Elekta, 22mm50-302-2202016-10-04
B365503022300Circular Small Field Cone Insert, Elekta, 23mm50-302-2302016-10-04
B365503022400Circular Small Field Cone Insert, Elekta, 24mm50-302-2402016-10-04
B365503022500Circular Small Field Cone Insert, Elekta, 25mm50-302-2502016-10-04
B365503022600Circular Small Field Cone Insert, Elekta, 26mm50-302-2602016-10-04
B365503022700Circular Small Field Cone Insert, Elekta, 27mm50-302-2702016-10-04
B365503022800Circular Small Field Cone Insert, Elekta, 28mm50-302-2802016-10-04
B365503022900Circular Small Field Cone Insert, Elekta, 29mm50-302-2902016-10-04
B365503023000Circular Small Field Cone Insert, Elekta, 30mm50-302-3002016-10-04

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Primary DI, Brand, Company table
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