ClearanceBrief
510(k) K203020 ยท JAK System, X-Ray, Tomography, Computed

Spectral CT

ApplicantPhilips Medical Systems Nederland B.V., Best Noord-Brabant, NL
DecisionSubstantially Equivalent, Feb 26, 2021
ReceivedOct 2, 2020
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K203020

DateFirm and productCodeLinked 510(k)
Jun 26, 2025Philips North America Llc
Spectral CT. Computed tomography X-ray system.
Open, Classified		 JAKNone listed
Dec 3, 2024Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Open, Classified		 JAKNone listed
May 2, 2024Philips North America Llc
The Oncology Essentials Package of the Spectral CT imaging system.
Open, Classified		 JAKNone listed
Feb 8, 2024PHILIPS MEDICAL SYSTEMS
Spectral CT 7500: Software Version 5.0, Model 728333 and Spectral CT 7500 China: Software Version 5.0, Model 728340.
Open, Classified		 JAKNone listed
Jan 12, 2024Philips North America Llc
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Open, Classified		 JAKNone listed
May 12, 2023Philips North America Llc
Spectral CT 7500 Computed Tomography X-Ray System, Model Number 728333
Open, Classified		 JAKNone listed
Jun 8, 2021Philips North America Llc
728333 Spectral CT 7500 -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 728333 - Spectral CT:
Open, Classified		 JAKNone listed

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