ClearanceBrief
510(k) K212875 ยท JAK System, X-Ray, Tomography, Computed

Spectral CT on Rails

ApplicantPhilips Medical Systems Nederland B.V., Best, NL
DecisionSubstantially Equivalent, May 13, 2022
ReceivedSep 9, 2021
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K212875

DateFirm and productCodeLinked 510(k)
Apr 16, 2026PHILIPS MEDICAL SYSTEMS
Philips Spectral CT on Rails. Model Number: 728334.
Open, Classified		 JAKNone listed
Feb 6, 2026Philips North America Llc
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Open, Classified		 JAKNone listed
Mar 12, 2025Philips Medical Systems Nederland B.V.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Open, Classified		 JAKNone listed
Feb 8, 2024PHILIPS MEDICAL SYSTEMS
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Open, Classified		 JAKNone listed
Nov 16, 2023Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Open, Classified		 JAKNone listed
Nov 15, 2023Philips North America
Spectral CT on Rails, Software Version 5.1.0, Model Number 728334
Open, Classified		 JAKNone listed

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