AccessGUDID - DEVICE: myQA iON (EIBAMQ100000)

GUDID

Device Identifier (DI) Information

Brand Name: myQA iON
Version or Model: MQ10-000
Commercial Distribution Status: In Commercial Distribution
Catalog Number:
Company Name: IBA Dosimetry GmbH

Primary DI Number: EIBAMQ100000
Issuing Agency: HIBCC
Commercial Distribution End Date:
Device Count: 1
Labeler D-U-N-S® Number*: 332599307 *Terms of Use

Device Description: myQA iON software

Device Characteristics

What MRI safety information does the labeling contain?	Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437):	No
Device labeled as "Not made with natural rubber latex":	No
For Single-Use:	No
Prescription Use (Rx):	Yes
Over the Counter (OTC):	No
Kit:	No
Combination Product:	No
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P):	No

GMDN

[?]

GMDN Term Code	GMDN Term Name	GMDN Term Definition	GMDN Term Status [?]	Implantable?
38399	Accelerator system quality assurance device	An 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.	Active	false

FDA Product Code

[?]

Product Code	Product Code Name
IYE	Accelerator, Linear, Medical
LHN	System, Radiation Therapy, Charged-Particle, Medical

FDA Premarket Submission

FDA Premarket Submission Number [?]	Supplement Number [?]
K201798	000

Device Exempt from Premarket Submission: No CLOSE

Sterilization

Device Packaged as Sterile: No
Requires Sterilization Prior to Use: No

Sterilization Method [?]
No Sterilization Methods Found

Storage and Handling

[?]

Storage and Handling
No storage/handling found

Clinically Relevant Size

[?]

Size Type Text
No Device Sizes

Device Record Status

Public Device Record Key: 21b7712d-2817-4cb0-8fd4-45b8e3d9200f
Public Version Date: April 19, 2021
Public Version Number: 1
DI Record Publish Date: April 09, 2021

Alternative and Additional Identifiers Additional Identifiers

Package DI

[?]

Package DI Number	Quantity per Package	Contains DI Package	Package Discontinue Date	Package Status	Package Type
No Package DIs found

Secondary DI

[?]

Issuing Agency [?]	Secondary DI Number
No Secondary DIs found

Unit of Use DI

[?]

Unit of Use DI Number: No Unit of Use DI Numbers Found CLOSE

Direct Marking (DM)

[?]

Device Subject to Direct Marking (DM), but Excepted: No
DM DI Different from Primary DI: No
DM DI Number: None
CLOSE

Production Identifier(s) in UDI

[?]

Lot or Batch Number: No
Serial Number: Yes
Expiration Date: No
Manufacturing Date: No
Donation Identification Number: No CLOSE

Customer Contact

[?]

Phone: +861080809107
Email: ServiceAPAC@iba-group.com

Phone: +1 901 386-2242
Email: USService@iba-group.com

Phone: +49912860738
Email: service@iba-group.com

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