← Back to catalogue

KV-Meter MagicMax mam

FDA UDI

Class I (US FDA UDI)

by IBA Dosimetry GmbH

Identity

Trade Name
KV-Meter MagicMax mam FDA UDI
Generic Name
Diagnostic x-ray system quality assurance device FDA UDI
Device Name
KV-Meter with fixed XM Multidetector, for kV and HVL measurements of mammography X-ray units, incl. kV-waveform. FDA UDI
Model / Reference
VD0201958 FDA UDI
Description
KV-Meter with fixed XM Multidetector, for kV and HVL measurements of mammography X-ray units, incl. kV-waveform. FDA UDI

Identifiers

Catalog Number
VD0201958 FDA UDI
Primary DI / UDI-DI
EIBAVD02019580 FDA UDI
FDA Product Code
LHO FDA UDI
GMDN Term
Diagnostic x-ray system quality assurance device FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
892.1940 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

No

FDA UDI

Serial Number

Yes

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI

Category: Diagnostic x-ray system quality assurance device

KV-Meter MagicMax mam by IBA Dosimetry GmbH — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Diagnostic x-ray system quality assurance device.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
IBA Dosimetry GmbH

Sources (1)

  • FDA UDI e3a47152-08ba-40fc-8fb3-d630bf943cc7 35 fields · synced May 30, 2026