System M STEP

GUDID 09120074398504

IT-V Medizintechnik GmbH

Radiological whole-body positioner
Primary Device ID09120074398504
NIH Device Record Key4fc56022-ae06-46d5-a809-8272c4a978cb
Commercial Distribution Discontinuation2021-06-25
Commercial Distribution StatusNot in Commercial Distribution
Brand NameSystem M STEP
Version Model NumberP10107-850
Company DUNS300005408
Company NameIT-V Medizintechnik GmbH
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS109120074398504 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

IYEAccelerator, Linear, Medical

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number6
Public Version Date2021-06-28
Device Publish Date2016-09-01

Devices Manufactured by IT-V Medizintechnik GmbH

09120074391000 - HeadSTEP Carbon Basic Module2024-11-11
09120074391017 - HeadSTEP Carbon Flat Basic Module2024-11-11
09120074391604 - BellySTEP Baseplate2024-11-11
09120074394001 - HeadSTEP MR Basic Module2024-11-11
09120074394025 - HeadSTEP iBEAM evo Extension Basic Module2024-11-11
09120074394124 - HeadSTEP IMRT Basic Module2024-11-11
09120074394131 - HeadSTEP Shoulder Basic Module2024-11-11
09120074394148 - HS iBEAM evo Extension Push Pin2024-11-11

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