FDA.reportPublic FDA data

KV-Meter MagicMax mam

Primary DI
EIBAVD02019580
Brand
KV-Meter MagicMax mam
Company
IBA Dosimetry GmbH
Model
VD0201958
Catalog number
VD0201958
Device description
KV-Meter with fixed XM Multidetector, for kV and HVL measurements of mammography X-ray units, incl. kV-waveform.
Published
2020-10-26
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Contact Domains#

Product Codes#

Code, Name table
CodeName
LHOInstrument, Quality-Assurance, Radiologic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
LHOInstrument, Quality-Assurance, RadiologicRadiology1

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
EIBAVD02019580PrimaryHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
X-ray system quality assurance device, x-ray tube simulatorAn instrument used for quality assurance (QA) purposes to assess the electronic performance of medical and dental x-ray generators that is designed to connect directly to the x-ray generator output, and replace the x-ray tube. It may include hardware, software, and associated electronics used to measure, display, and record parameters, e.g., kVp, pulse time, voltage, waveform, or amperage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1 786 288 0369service-usa@iba-group.com

Regulatory Flags#

DUNS number
332599307
Device count
1
DM exempt
false
Premarket exempt
true
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
EIBASR020010myQA® SRS Phantom CyberknifeSR02001SR02-0012023-10-10
EIBAHA03000V0040Lift tableHA03-000#004HA03-000#0042023-09-19
EIBAHA03010V0040Lift tableHA03-010#004HA03-010#0042023-09-19
EIBAHA050000Water ReservoirHA05-000HA05-0002023-08-03
EIBAHA050100Water ReservoirHA05-010HA05-0102023-08-03
EIBAE30702001myQA SRS Detector Cyberknife editionE3070200SR01-1002023-07-25
EIBAE20702000DOSE-XE2070200DX00-0002023-04-13
EIBAE20703000DOSE-XE2070300DX00-1002023-04-13
EIBABS505001miniPhantomBS50-500BS50-5002023-04-12
EIBAE14000300CCU Steuerelektronik PTE14000302023-04-12
EIBAHA031150Lift tableHA03-115HA03-1152023-04-12
EIBAHA032300Lift tableHA03-230HA03-2302023-04-12
EIBA120104HS0KermaX-plus1120-104 HS2021-12-17
EIBA120104HSE1KermaX-plus1120-104 HS E2021-12-17
EIBA120104HST1KermaX-plus1120-104 HS T2021-12-17
EIBA120104MICRO1KermaX-plus1120-104 MICRO2021-12-17
EIBA120104TINO1KermaX-plus1120-104 TINO2021-12-17
EIBA120121C1KermaX-plus1120-121C2021-12-17
EIBA120121CPLENO1KermaX-plus1120-121CPLENO 2021-12-17
EIBA120122C1KermaX-plus1120-122C2021-12-17

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07540161940157HYPERSCINT QAMedscint Inc.LHO2026-01-13
00811376030863Adapt LTE powered by Accuray CenosAccuray IncorporatedLHO2025-12-19
G34310010261IBA QUASAR™ Programmable Respiratory Motion Phantom 2Modus Medical Devices IncLHO2025-12-17
G34310010280QUASAR Static PhantomModus Medical Devices IncLHO2025-12-17
07340201503782AQUAElekta Solutions ABLHO2025-12-10
07340201500101AQUAElekta Solutions ABLHO2025-05-15
09421904268340Volpara Live VOLPARA HEALTH TECHNOLOGIES LIMITEDLHO2025-05-06
00855141006417MaximQAVARIAN MEDICAL SYSTEMS, INC.LHO2025-03-04
00810106410807Gafchromic™ASHLAND SPECIALTY INGREDIENTS G.P.LHO2025-02-13
04995047067740RadiCSEIZO CORPORATIONLHO2024-11-08
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B3658080000isoPoint Validation SoftwareAktina Corp.LHO2024-07-01
04547410538861FCR 1Shot Phantom PlusFUJIFILM CORPORATIONLHO2024-06-07
G34310010231000QUASARModus Medical Devices IncLHO2024-04-15
G34310010240QUASARModus Medical Devices IncLHO2024-04-15
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G34350037650QUASARModus Medical Devices IncLHO2024-04-15
G34350037700QUASARModus Medical Devices IncLHO2024-04-15
EPTWT100560OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29
EPTWT100570OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29
EPTWT100580OCTAVIUSPTW-Freiburg Physikalisch-Technische Werkstätten Dr. Pychlau GmbHLHO2023-11-29