ClearanceBrief
Panels › Radiology › Product code JAK · Class 2

System, X-Ray, Tomography, Computed

Regulation 892.1750

22510(k)s in 12 months (827 all time)
38recalls in 12 months (872 all time)
795recalls that name a 510(k)
Get daily alerts for JAKSample briefCSV

Top companies in JAK

DateFirm and productCodeLinked 510(k)
Oct 2, 2026PHILIPS MEDICAL SYSTEMS
Spectral CT and Spectral CT 7500 RT; Software Version Numbers: 5.2.X (U.S.); 5.0.X, 5.2.X, 5.4.X (Outside U.S.); Model Numbers: 1. 728333 (U.S. and Outside U.S.), 2. 728340 (Outside U.S.), 3. 728344 (
Open, Classified
JAKK244008
Sep 29, 2026Philips North America Llc
Philips Medical Systems Technologies Ltd. Spectral CT 7500, Software V5.2.x, Product Code 728333
Open, Classified
JAKK244008
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT ATLAS Astound with software
Open, Classified
JAKK203448
K231482 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT ATLAS with software
Open, Classified
JAKK203448
K231482 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 780 with software
Open, Classified
JAKK172135
K230162 +2
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 760 with software
Open, Classified
JAKK172135
K230162
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 550 with software
Open, Classified
JAKK181414
K200016 +1
Sep 25, 2026Shanghai United Imaging Healthcare Co., Ltd.
Computed Tomography X-ray System, Model: uCT 530 with software
Open, Classified
JAKK181414
K200016
Sep 1, 2026Philips North America Llc
Philips Brilliance CT 64: Brilliance CT 64 Channel Product Code: 728231, Brilliance CT 64 Upgrades Product Code: 728232. Software 4.1.10.x
Open, Classified
JAKK033326
Sep 1, 2026Philips North America Llc
Philips Ingenuity CT Product Codes: Ingenuity CT Upgrades 728327, Ingenuity CT China 728324, Ingenuity Core 128 Elite Brazil 728325. Software 4.4.10.x
Open, Classified
JAKK160743
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
JAKK193454
Sep 1, 2026Philips North America Llc
Philips Brilliance. Models: Brilliance iCT, Brilliance iCT Upgrades, Brilliance iCT SP. Software 4.1.10.x Product Codes: 728306, 728305, 728311.
Open, Classified
JAKK250648
Aug 21, 2026Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT with software V4.5&V5.0, Product Code 728143 and Product Code 728144.
Open, Classified
JAKK212441
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
Ingenuity CT CT5000 Ingenuity Plus CT5000 Ingenuity Pro CT5000 Ingenuity Premium Ingenuity CT Upgrades Ingenuity CT China Ingenuity Core 128 Elite Brazil
Open, Classified
JAKK160743
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
IQon Spectral CT IQon Spectral CT Upgrades
Open, Classified
JAKK193454
Jul 27, 2026PHILIPS MEDICAL SYSTEMS
Brilliance iCT Brilliance iCT Upgrades Brilliance iCT SP Brilliance CT 64 Channel CT6000 Brilliance 64 Upgrades
Open, Classified
JAKK250648
May 8, 2026GE Medical Systems, LLC
Revolution Apex Select, X-ray Computed Tomography, Model Number 5590000-27
Open, Classified
JAKK213715
May 8, 2026GE Medical Systems, LLC
Revolution Apex, X-ray Computed Tomography, Model Number 5590000-20
Open, Classified
JAKK163213
K191777 +1
May 8, 2026GE Medical Systems, LLC
Revolution CT ES, X-ray Computed Tomography, Model Number 5590000-15
Open, Classified
JAKK163213
K191777 +1
May 8, 2026GE Medical Systems, LLC
Revolution Apex Plus, X-ray Computed Tomography, Model Number 5590000-25
Open, Classified
JAKK191777
K213715
May 8, 2026GE Medical Systems, LLC
Revolution Apex Elite, X-ray Computed Tomography, Model Number 5590000-23
Open, Classified
JAKK213715
May 8, 2026GE Medical Systems, LLC
Revolution CT, x-ray computed tomography, Model Numbers 5590000 and 5590000-6
Open, Classified
JAKK133705
K163213 +2
May 8, 2026GE Medical Systems, LLC
Revolution Ascend, computed tomography, Model Numbers 6969000-100 and 6969000-300
Open, Classified
JAKK213938
Apr 16, 2026PHILIPS MEDICAL SYSTEMS
Philips Spectral CT on Rails. Model Number: 728334.
Open, Classified
JAKK212875
Mar 20, 2026GE Medical Systems, LLC
Imactis CT-Navigation System, stereotaxic accessory for Computer Tomography (CT), systems, Model Numbers E85101LA and E85101LP
Open, Classified
JAKK162314
Feb 6, 2026Philips North America Llc
Spectral CT 7500 on Rails; Product Code (REF): 728334;
Open, Classified
JAKK212875
Feb 6, 2026Philips North America Llc
Spectral CT; Product Code (REF): 728333;
Open, Classified
JAKK244008
Feb 6, 2026Philips North America Llc
IQon Spectral CT; Product Code (REF): 728332;
Open, Classified
JAKK193454
Feb 6, 2026Philips North America Llc
Brilliance iCT; Product Code (REF): 728306;
Open, Classified
JAKK250648
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha.Pro Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified
JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha.Prime Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified
JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
NAEOTOM Alpha Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified
JAKK251061
Feb 3, 2026Siemens Medical Solutions USA, Inc
SOMATOM X.ceed Software applications: syngo.CT Brain Quantification syngo.CT Vessel Hyperdensities syngo.CT ASPECTS
Open, Classified
JAKK233650
Jan 9, 2026Mobius Imaging, LLC
Detachable 10in Pendant Upgrade component for the AIRO Computed Tomography (CT) X-ray System.
Open, Classified
JAKK180393
Jan 9, 2026Mobius Imaging, LLC
Detachable 10in Pend FRU-1 Pend component for the AIRO Computed Tomography (CT) X-ray System.
Open, Classified
JAKK180393
Jan 8, 2026Philips Healthcare (Suzhou) Co., Ltd.
Philips Incisive CT
Open, Classified
JAKK180015
K212441
Dec 3, 2025Philips North America Llc
CT 5300; Software Version Number: 4.5, 5.0, 5.1;
Open, Classified
JAKK232491
Dec 3, 2025Philips North America Llc
Incisive CT; Software Version Number: 4.5, 5.0, 5.1;
Open, Classified
JAKK180015
K212441 +1
Oct 27, 2025PHILIPS MEDICAL SYSTEMS
Model: Incisive CT for Brazil SKD; Product Code (REF): 728146; Software Versions: 5.1.0.X & 5.1.1.X;
Open, Classified
JAKK180015
K212441 +1
Oct 27, 2025PHILIPS MEDICAL SYSTEMS
Model: CT 5300; Product Code (REF): 728285; Software Versions: 5.1.0.X & 5.1.1.X;
Open, Classified
JAKK180015
K212441 +1
Oct 27, 2025PHILIPS MEDICAL SYSTEMS
Model: Incisive CT; Product Code (REF): (1) 728143, (2) 728144; Software Versions: 5.1.0.X & 5.1.1.X;
Open, Classified
JAKK180015
K212441 +1
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI Panorama 35 MD, Rx Only
Open, Classified
JAKK223325
K232712
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 780 MD, Rx Only
Open, Classified
JAKK172143
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uMI 550 MD, Rx Only
Open, Classified
JAKK182237
K193241
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Positron Emission Tomography and Computed Tomography System Model:uEXPLORER MD, Rx Only
Open, Classified
JAKK231762
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT ATLAS MD, Rx Only
Open, Classified
JAKK203448
K231482 +1
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 780 MD, Rx Only
Open, Classified
JAKK172135
K230162 +1
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 760 MD, Rx Only
Open, Classified
JAKK172135
K230162
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 550 MD, Rx Only
Open, Classified
JAKK181414
K200016
Oct 21, 2025UIH Technologies LLC
Shanghai United Imaging Healthcare Co., Ltd. Computed Tomography X-ray System, Model:uCT 530 MD, Rx Only
Open, Classified
JAKK181414
K200016

Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.