Home GUDID B365548830 Simulator Dot Reticle Set
Primary DI B365548830
Brand Simulator Dot Reticle Set
Company Aktina Corp.
Model 54-883
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 Code Name IWE Monitor, Patient Position, Light-Beam
Product Code Classifications# Code, Device, Specialty table Code Device Specialty Class IWE Monitor, Patient Position, Light-Beam Radiology 1
Identifiers And Packaging# Identifier, Type, Agency table Identifier Type Agency Package quantity Status B365548830 Primary HIBCC 0
GMDN Terms# Term, Definition table Term Definition Patient positioning patterned-light instrument A 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.
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 DI Brand Model Catalog Published B365112200 Head and Neck Overlay with Shoulder Restraints 11-220 2016-09-24 B365805000 Navigator CS 80-500 2016-09-24 B3658080000 isoPoint Validation Software 80-800 2024-07-01 B365601900 Belly Compression Arch Kit 60-190 2016-09-24 B365603100 Respiratory Belt with Bladder, Small 60-310 2016-09-28 B365603110 Respiratory Belt with Bladder, Medium 60-311 2016-09-28 B365603120 Respiratory Belt with Bladder, Large 60-312 2016-09-28 B365503710 Transport Cart, SRS Cones 50-371 2021-05-21 B365503720 Bar Code Reader Kit 50-372 2021-05-21 B365503750 Film Holder 50-375 2021-05-21 B365503022100 Circular Small Field Cone Insert, Elekta, 21mm 50-302-210 2016-10-04 B365503022200 Circular Small Field Cone Insert, Elekta, 22mm 50-302-220 2016-10-04 B365503022300 Circular Small Field Cone Insert, Elekta, 23mm 50-302-230 2016-10-04 B365503022400 Circular Small Field Cone Insert, Elekta, 24mm 50-302-240 2016-10-04 B365503022500 Circular Small Field Cone Insert, Elekta, 25mm 50-302-250 2016-10-04 B365503022600 Circular Small Field Cone Insert, Elekta, 26mm 50-302-260 2016-10-04 B365503022700 Circular Small Field Cone Insert, Elekta, 27mm 50-302-270 2016-10-04 B365503022800 Circular Small Field Cone Insert, Elekta, 28mm 50-302-280 2016-10-04 B365503022900 Circular Small Field Cone Insert, Elekta, 29mm 50-302-290 2016-10-04 B365503023000 Circular Small Field Cone Insert, Elekta, 30mm 50-302-300 2016-10-04
Other Devices Sharing Product Codes# Primary DI, Brand, Company table Primary DI Brand Company Product code Published 06977071936009 Meicen Guangdong Meicen Medical Equipment Co., Ltd. IWE 2024-06-21 00840348505344 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505351 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-12 00840348505368 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505375 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505382 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505399 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-12 00840348505405 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505412 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-12 00840348505429 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-12 00840348505436 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505443 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505450 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-12 00840348505467 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505474 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505498 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505504 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348505788 AADCO AADCO MEDICAL, INC. IWE 2022-12-12 00840348502398 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502404 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-09 00840348502411 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502428 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502435 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502442 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-09 00840348502459 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502466 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-09 00840348502473 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502480 Hercules AADCO MEDICAL, INC. IWE 2022-12-09 00840348502497 MRI-Safe AADCO MEDICAL, INC. IWE 2022-12-09 00840348502503 Hercules AADCO MEDICAL, INC. IWE 2022-12-09