FDA.reportPublic FDA data

IQM Integral Quality Monitor

Primary DI
B50510130
Brand
IQM Integral Quality Monitor
Company
iRT Systems GmbH
Model
1013 (vers 1.3)
Device description
IQM is quality assurance device for medical linear accelerators for verifying the treatment beam.
Published
2017-02-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

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
K162629000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K162629000IQM Integral Quality Monitor (also IQM)Irt Systems2016-10-20IYE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
B50510130PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Accelerator system quality assurance deviceAn instrument specifically designed to be used to check the calibration and performance of linear and non-linear medical accelerator systems used for radiation therapy applications, for quality assurance (QA) purposes. It includes a variety of instruments used to measure parameters associated with particle and photon beam production, beam quality, and other system performance parameters.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+49261915450support@i-rt.de

Regulatory Flags#

DUNS number
342751065
Device count
1
Serial number
true
Manufacturing date on label
true

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Primary DI, Brand, Company table
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