ClearanceBrief
510(k) K203087 ยท JAA System, X-Ray, Fluoroscopic, Image-Intensified

CombiDiagnost R90

ApplicantPhilips Medical Systems Dmc GmbH, Hamburg, DE
DecisionSubstantially Equivalent, Dec 3, 2020
ReceivedOct 13, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K203087

DateFirm and productCodeLinked 510(k)
Feb 14, 2024PHILIPS MEDICAL SYSTEMS
CombiDiagnost R90 1.1 (709031)
Open, Classified		 JAANone listed
Nov 8, 2023Philips North America Llc
CombiDiagnost R90, Radiography and Fluoroscopy (R/F) system
Open, Classified		 JAANone listed
May 15, 2023Philips North America
CombiDiagnost R90 R1.1
Open, Classified		 JAANone listed
Apr 10, 2023Philips North America Llc
CombiDiagnost R90 1.0 and 1.1 multi-functional general R/F system, Model Numbers 709030 and 709031
Open, Classified		 JAANone listed
Sep 22, 2021Philips Healthcare
CombiDiagnost R90 is multi-functional general R/F systems.
Open, Classified		 JAANone listed
Jul 22, 2020Philips Medical Systems Gmbh, DMC
CombiDiagnost R90 Software Version R1.0 and R1.1
Open, Classified		 JAANone listed

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