FDA.reportPublic FDA data

System HeadSTEP Bite Wide

Primary DI
09120074397910
Brand
System HeadSTEP Bite Wide
Company
IT-V Medizintechnik GmbH
Model
P10107-791
Published
2016-09-01
Public version status
Update
Distribution status
Not 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
K081218000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K081218000BELLYSTEP, HEADSTEP, BREASTSTEP, PROSTEP, WINGSTEP AND ICASTIt-V Medizintechnik, GmbH2008-07-21IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
09120074397910PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
09120074397910091200743979109120074397910

GMDN Terms#

Term, Definition table
TermDefinition
Radiological whole-body positionerA device comprised of fixed or adjustable position elements designed to ensure adequate positioning and/or immobilization of a patient's whole body during diagnostic imaging, image guided surgical or interventional procedures, and/or radiation therapy procedures; it may in addition be used to position a patient’s body part (however it is not dedicated to a specific part of the body). It is in the form of a frame, board, cushion, or preformed pad and may be used to facilitate reproducible positioning for serial imaging studies or serial radiation therapy treatments.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
300005408
Device count
1
Lot or batch
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
09120074394063HS Indexing AdapterP10107-4062016-09-01
09120074394339HS Indexing Adapter Elekta 530P10107-4332016-09-01
09120074397040System HeadSTEP MR glasfibreP10107-7042016-09-01
09120074394001HeadSTEP MR Basic ModuleP10107-4002016-09-01
09120074395176HS S-TYPE Basic Module MRP10107-5172018-04-16
09120074397194System HS S-TYPE MRP10107-7192018-04-16
09120074394490HS Bite Angulating Fixation Set WideP10107-4492016-09-01
09120074396364Wall holder for CT STEPP10107-6362016-09-01
09120074394018HeadSTEP IMRT MR Basic ModuleP10107-4012024-11-12
09120074395312WingSTEP high for Varian BaseplateP10107-5312024-11-12
09120074395329WingSTEP low for Varian BaseplateP10107-5322024-11-12
09120074395404BreastSTEP Short Mask Basic ModuleP10107-5402024-11-12
09120074395411BreastSTEP Long Mask Basic ModuleP10107-5412024-11-12
09120074395428BreastSTEP Short MR Basic ModuleP10107-4372024-11-12
09120074395435BreastSTEP Long MR Basic ModuleP10107-5432024-11-12
09120074391000HeadSTEP Carbon Basic ModuleP10107-1002016-09-01
09120074391017HeadSTEP Carbon Flat Basic ModuleP10107-1012016-09-01
09120074391604BellySTEP BaseplateP10107-1602016-09-01
09120074394025HeadSTEP iBEAM evo Extension Basic ModuleP10107-4022016-09-01
09120074394124HeadSTEP IMRT Basic ModuleP10107-4122016-09-01

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