FDA.reportPublic FDA data

Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens

Primary DI
B36556300DX600
Brand
Wedge Filter, Cross- Plane, Digital, 60 Degrees, Siemens
Company
Aktina Corp.
Model
56-300-DX60
Published
2016-09-24
Public version status
Update
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
K014081000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K014081000AKTINA MEDICAL PHYSICS RADIATION THERAPY WEDGESAktina Medical Physics Corp.2002-03-05IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B36556300DX600PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray/radiation therapy beam filter, wedgeA wedge-shaped metal filter placed in a beam of primary radiation before it reaches the patient undergoing radiation therapy or imaging procedure. In radiation therapy it ensures uniform irradiation of body areas that vary in thickness or density. In diagnostic imaging it is used to obtain films of a more uniform density when the part being examined diminishes greatly in thickness from one side of the field to the other. It is typically made from aluminium (Al), lead (Pb), copper (Cu), tin (Sn) or combinations of these. Also called compensation filter because when one side of a patient is considerably thicker/denser than the other, the wedge compensates for the physical difference.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
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B365603110Respiratory Belt with Bladder, Medium60-3112016-09-28
B365603120Respiratory Belt with Bladder, Large60-3122016-09-28
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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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