ClearanceBrief
510(k) K111725 ยท IZL System, X-Ray, Mobile

MOBILEDIAGNOST WDR

ApplicantSedecal., Sa., Seneca SC, US
DecisionSubstantially Equivalent, Jul 19, 2011
ReceivedJun 20, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K111725

DateFirm and productCodeLinked 510(k)
Oct 23, 2025SEDECAL SA
MobileDiagnost wDR 2.2; Model Number REF 9890-010-89522, Mobile X-ray system
Open, Classified		 IZLNone listed
Feb 14, 2024SEDECAL SA
MobileDiagnost wDR, Model numbers 712001, 712002, 712004, 712006, and 712007
Open, Classified		 IZLNone listed
Jan 18, 2016Sedecal S.A.
Mobile wDR motorized portable diagnostic X-ray systems. Intended for use by a qualified/trained doctor or technologist on both adult and pediatric patients for taking diagnostic radiographic exposures
Terminated		 IZLNone listed
Mar 23, 2015Sedecal USA, Inc.
Sedecal SA Mobile Diagnost w DR x-ray system
Terminated		 IZLNone listed
Feb 2, 2015Sedecal S.A.
MobileDiagnost wDR motorized portable diagnostic X-ray systems.
Terminated		 IZLNone listed
Dec 16, 2014Philips Medical Systems, Inc.
Intended for both adult and pediatric patients for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts on both adult and pediatric p
Terminated		 IZLNone listed
Aug 21, 2013Philips Healthcare Inc.
Philips Healthcare MobileDiagnostwDR system. Mobile Digital radiography X-Ray System Product Usage: MobileDiagnost wDR is a mobile digital radiography X-Ray System. It is intended for use by a qual
Terminated		 IZLNone listed
Nov 28, 2012Philips Healthcare Inc.
Mobile Diagnostic X-Ray System with Digital Panel
Terminated		 IZLNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.