ClearanceBrief
510(k) K193454 ยท JAK System, X-Ray, Tomography, Computed

IQon Spectral CT

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Jan 24, 2020
ReceivedDec 13, 2019
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K193454

DateFirm and productCodeLinked 510(k)
Sep 1, 2026Philips North America Llc
Philips IQon Spectral CT Product Codes: IQon Spectral CT 728332, IQon Spectral CT 728331 Software 4.7.7.x
Open, Classified		 JAKNone listed
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
IQon Spectral CT IQon Spectral CT Upgrades
Open, Classified		 JAKNone listed
Feb 6, 2026Philips North America Llc
IQon Spectral CT; Product Code (REF): 728332;
Open, Classified		 JAKNone listed
Jun 8, 2021Philips North America Llc
728332 IQon Spectral CT-Computed Tomography X-ray system
Terminated		 JAKNone listed
May 1, 2021Philips North America Llc
Continuous CT Fluoroscopy DVI Ceiling Mount CCT Arm DVI Option - Monitor 728332 - IQon Spectral CT : IQon Spectral CT
Open, Classified		 JAKNone listed
May 6, 2020Philips North America, LLC
Philips Brilliance IQon Spectral CT, Computed Tomography X-Ray System; Model # 728332; UDI # (01)00884838059542(21)860067
Terminated		 JAKNone listed

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