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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)
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Top companies in JAK

DateFirm and productCodeLinked 510(k)
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. CT 6000, Model Number: 728307.
Open, Classified
JAKK033326
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT Family Brazil, Model Number: 728325.
Open, Classified
JAKK033326
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity Core128 / Elite China, Model Number: 728324.
Open, Classified
JAKK033326
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. IQon Spectral CT, Model Number: 728332.
Open, Classified
JAKK163711
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Ingenuity CT 728326, Model Number: 728321. 2. Ingenuity CT 728326, Model Number: 728323. 3. Ingenuity CT, Model Number: 728326.
Open, Classified
JAKK160743
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT SP, Model Number: 728311.
Open, Classified
JAKK060937
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance iCT, Model Number: 728306.
Open, Classified
JAKK162838
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Big Bore RT, Model Number: 728242. 2. Brilliance CT Big Bore Oncology, Model Number: 728243. 3. Brilliance CT Big Bore, Model Number: 728244.
Open, Classified
JAKK171850
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance 16 Power, Model Number: 728240. 2. Brilliance CT 16 Slice, Model Number: 728246. 3. Brilliance CT 6 Slice, Model Number: 728256.
Open, Classified
JAKK012009
Sep 19, 2025Philips North America Llc
Philips CT systems labeled as the following: 1. Brilliance CT 40 Channel, Model Number: 728235. 2. Brilliance CT 64 Channel, Model Number: 728231. 3. Ingenuity Flex, Model Number: 728317
Open, Classified
JAKK033326
Jun 26, 2025Philips North America Llc
Spectral CT. Computed tomography X-ray system.
Open, Classified
JAKK203020
Jun 9, 2025QUANTUM SURGICAL SAS
EPIONE Model 30-0001 UDI-DI code: 03760305400031 The EPIONE device is a user controlled, stereotactic accessory intended to assist in the planning and manual advancement of one or more instruments, a
Open, Classified
JAKK223758
Apr 23, 2025Philips North America Llc
Philips Brilliance CT Big Bore, Software Version 4.8.0.10430. Computed Tomography X-Ray System.
Open, Classified
JAKK171850
Mar 12, 2025Philips Medical Systems Nederland B.V.
Spectral CT on Rails, Software Version Number 5.1.0, Model number: 728334;
Open, Classified
JAKK212875
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution CT ES, System, X-ray, Tomography, Computed
Open, Classified
JAKK163213
K191777 +1
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution CT, System, X-ray, Tomography, Computed
Open, Classified
JAKNone listed
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution Apex Select, System, X-ray, Tomography, Computed
Open, Classified
JAKK213715
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution Apex Plus, System, X-ray, Tomography, Computed
Open, Classified
JAKK191777
K213715
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution Apex Expert, System, X-ray, Tomography, Computed
Open, Classified
JAKNone listed
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution Apex Elite, System, X-ray, Tomography, Computed
Open, Classified
JAKK213715
Mar 7, 2025GE Medical Systems, LLC
GE Healthcare Revolution Apex, System, X-ray, Tomography, Computed
Open, Classified
JAKK163213
K191777 +1
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80662DA: China Only: Discovery CT750HD
Open, Classified
JAKK081105
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80522DA: China Only: Revolution Discovery CT
Open, Classified
JAKK081105
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B80212DA: EU: Operator Console (for BrightSpeed, Elite/BrightSpeed Elite Select), Non-EU: BrightSpeed Elite, BrightSpeed Elite
Open, Classified
JAKK052855
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Operator Console Upgrade Types, FRU Spare Parts Number B79632DA: EU: RT Refresh Package, Non-EU: Discovery RT, Optima CT580, or Discovery CT590 RT; X-ray/computed tomography system
Open, Classified
JAKK093581
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima Select, Model Number, 6670000-55; X-ray/computed tomography system
Open, Classified
JAKK192686
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima M, Model Number, 6670000-2; X-ray/computed tomography system
Open, Classified
JAKK192686
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Maxima, Model Numbers: 1) 6665000-2, 2) 6670000-2, 3) 6670000-200, 4) 6670000-6; X-ray/computed tomography system
Open, Classified
JAKK192686
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Frontier, Model Numbers: 1) 5232085-213, 2) 5873009; X-ray/computed tomography system
Open, Classified
JAKK120833
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution EVO, Model Number 5454001-260; X-ray/computed tomography system
Open, Classified
JAKK131576
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Eagle, Model Number 5849504-3, X-ray/computed tomography system
Open, Classified
JAKNone listed
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Ascend Elite, Model Number 6967000-100; X-ray/computed tomography system
Open, Classified
JAKK192686
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Ascend, Model number 6969000-100; X-ray/computed tomography system
Open, Classified
JAKK213938
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution Advance, Model number 5849504; X-ray/computed tomography systems
Open, Classified
JAKK123596
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Revolution ACE, Model number 6670000-3; X-ray/computed tomography systems
Open, Classified
JAKK192686
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Optima 680 Expert, Model number 6670000; X-ray/computed tomography system
Open, Classified
JAKNone listed
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Optima 520, Catalog number 5439126; X-ray/computed tomography systems
Open, Classified
JAKK123596
Dec 4, 2024GE Healthcare (China) Co., Ltd.
GE Healthcare Discovery RT, Model Number 2374681-17, X-ray/computed tomography systems labeled as:
Open, Classified
JAKK093581
Dec 3, 2024Philips North America Llc
Spectral CT and Spectral CT Plus. Model Numbers: 728333, 728340, 728344.
Open, Classified
JAKK203020
Dec 2, 2024Orthoscan, Inc.
Ziehm Vision system, x-ray, tomography, computed.
Open, Classified
JAKK073346
Oct 9, 2024QUANTUM SURGICAL SAS
The EPIONE device v1.0.2 is a user controlled, stereotactic accessory device intended to assist in the planning and manual advancement of one or more instruments, as well as in verification of instrum
Completed
JAKK223758
May 20, 2024Philips North America Llc
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728144
Open, Classified
JAKK212441
May 20, 2024Philips North America Llc
Incisive CT - Computed Tomography X-Ray System intended to produce cross-sectional images of the body. Model Number: 728143
Open, Classified
JAKK180015
May 2, 2024Philips North America Llc
The Oncology Essentials Package of the Spectral CT imaging system.
Open, Classified
JAKK203020
Apr 9, 2024Philips North America
PHILIPS Incisive Computed tomography X-ray system Incisive CT Software Upgrade from V4.5.1.41921 to V4.5.1.41989-Intended to produce cross-sectional images of the body Model Number: 728143
Open, Classified
JAKK180015
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
JAKK203020
Feb 8, 2024PHILIPS MEDICAL SYSTEMS
Spectral CT on Rails: Software Version 5.1.0.X, model 728334.
Open, Classified
JAKK212875
Jan 12, 2024Philips North America
Incisive CT, Model Numbers 728144 and 728143. Computed Tomography X-Ray System PIM cable part number 459801179871
Open, Classified
JAKK180015
K212441
Jan 12, 2024Philips North America Llc
Spectral CT 7500, Software Version 5.0.0.X. Computed Tomography X-Ray System.
Open, Classified
JAKK203020
Jan 5, 2024Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT, model 728143 & 728144 running Software Version 5.0.0.
Open, Classified
JAKK180015
K212441

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