Thermoplastic Head Mask Support Assembly

Primary DI
B365502650
Brand
Thermoplastic Head Mask Support Assembly
Company
Aktina Corp.
Model
50-265
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
IYEAccelerator, Linear, Medical

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
IYEAccelerator, Linear, MedicalRadiology2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K103616000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K103616000PINPOINT STEREOTACTIC HEAD AND NECK LOCALIZERAktina Medical Physics Corp.2011-01-25IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B365502650PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Stereotactic radiosurgical/radiotherapy arch head frameA non-sterile device intended to be used to position and immobilize a patient’s head for reproducible positioning during radiation treatment planning, stereotactic radiotherapy (SRT), and stereotactic radiosurgery (SRS), on all parts of the brain, head, and neck. It is in the form of an arched frame to which can be attached various components (e.g., mouthpiece, nasion cushion) that non-invasively contact the patient to serve as points of reference, and which is typically attached to a base plate, couch top, or overlay. This is a reusable device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
787178920
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Model table
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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
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Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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08057014731231LIAC HWLS.I.T. SORDINA IORT TECHNOLOGIES SPAIYE2026-04-30
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08720168162564DSPS-Prominent® Cradle-IIMACROMEDICS B.V.IYE2026-04-22
08720168162571Mask DSPS®-PROSHVRL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162618Mask DSPS®-PROSHL set/5MACROMEDICS B.V.IYE2026-04-22
08720168162649Mask DSPS®-PROSHVR set/5MACROMEDICS B.V.IYE2026-04-22
08720168162748Mask DSPS®-PROH, set/5MACROMEDICS B.V.IYE2026-04-22
08720168162755Mask DSPS®-PRO, set/5MACROMEDICS B.V.IYE2026-04-22
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08720168162786DSPS-Prominent® Cradle-IVMACROMEDICS B.V.IYE2026-04-22
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08720168162908Handgrips HNS, set/2MACROMEDICS B.V.IYE2026-04-21
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