myQA SRS Detector Cyberknife edition SR01-100

GUDID EIBAE30702001

myQA SRS Cyberknife edition

IBA Dosimetry GmbH

Accelerator system quality assurance device
Primary Device IDEIBAE30702001
NIH Device Record Key1d74acb8-6c3b-4651-877e-0d09fd13e9bc
Commercial Distribution StatusIn Commercial Distribution
Brand NamemyQA SRS Detector Cyberknife edition
Version Model NumberE3070200
Catalog NumberSR01-100
Company DUNS332599307
Company NameIBA Dosimetry 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

Customer Support Contacts

Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com
Phone+49912860738
Emailservice@iba-group.com

Device Identifiers

Device Issuing AgencyDevice ID
HIBCCEIBAE30702000 [Primary]
HIBCCEIBAE30702001 [Package]
Contains: EIBAE30702000
Package: Carry Case [1 Units]
In Commercial Distribution

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 StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-08-02
Device Publish Date2023-07-25

Devices Manufactured by IBA Dosimetry GmbH

EIBASR020010 - myQA® SRS Phantom Cyberknife2023-10-18 myQA® SRS Phantom Cyberknife for myQA SRS detector for SRS and SBRT patient plan verification
EIBAHA03000V0040 - Lift table2023-09-27 Electric Lift Table Type 230V
EIBAHA03010V0040 - Lift table2023-09-27 Electric Lift Table Type 115V
EIBAHA050000 - Water Reservoir2023-08-11 Waterreservoir - bidirectional pump, 230V
EIBAHA050100 - Water Reservoir2023-08-11 Waterreservoir - bidirectional pump, 115V
EIBAE30702001 - myQA SRS Detector Cyberknife edition2023-08-02myQA SRS Cyberknife edition
EIBAE30702001 - myQA SRS Detector Cyberknife edition2023-08-02 myQA SRS Cyberknife edition
EIBAE20702000 - DOSE-X2023-04-21 DOSE-X Dosimeter TNC
EIBAE20703000 - DOSE-X2023-04-21 DOSE-X Dosimeter BNC

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