Iba Dosimetry

FDA Regulatory Profile

Summary

Total Recalls
6
510(k) Clearances
3
Inspections
1
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1703-2025Class IImyQA iON; Article Number: MQ10-000;April 1, 2025
Z-2220-2017Class IILarge Stealth Chamber, Catalog Numbers: DS50-001-XL-T, DS50-002-XL-T, DS50-003-XL-T, DS50-102-XLApril 26, 2017
Z-0683-2016Class IIIBA Dosimetry GmbH Lift Table Type 4320, Catalog HA03-010#2 and HA03-000#2December 10, 2015
Z-1212-2015Class IICOMPASS SW Version 3.1, Catalog Number CS10-100, medical linear accelerator, radiologicalFebruary 2, 2015
Z-0168-2015Class IICOMPASS, Model No. SW Version 3.1, catalogue number CS10-100 (medical Linear accelerator) radiologicSeptember 25, 2014
Z-0456-2014Class IIiba COMPASS SW Version 3.0, Catalog Number CS10-100 (medical linear accelerator) radiologicalAugust 20, 2013

Recent 510(k) Clearances

K-NumberDeviceDate
K201798myQA iONJuly 17, 2020
K191821Blue Phantom PTJanuary 23, 2020
K092018OMNIPRO INCLINESeptember 18, 2009