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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, x-ray, tomography, computed
Regulation Description Computed tomography x-ray system.
Product CodeJAK
Regulation Number 892.1750
Device Class 2


Premarket Reviews
ManufacturerDecision
4DMEDICAL LIMITED
  SUBSTANTIALLY EQUIVALENT 2
4DX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
AIDOC MEDICAL , LTD.
  SUBSTANTIALLY EQUIVALENT 1
ANALOGIC CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ARINETA , LTD.
  SUBSTANTIALLY EQUIVALENT 4
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 2
BUNKERHILL HEALTH
  SUBSTANTIALLY EQUIVALENT 3
BUNKERHILL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 20
CASCINATION AG
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 2
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
COVIDIEN, LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 2
FLUIDDA, INC.
  SUBSTANTIALLY EQUIVALENT 1
FMI MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM HEALTHCARE AMERICAS CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
FUJIFILM HEALTHCARE CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HANGWEI MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 9
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 10
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 3
IMAGING BIOMETRICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISYS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
LEO CANCER CARE
  SUBSTANTIALLY EQUIVALENT 1
MEVIS MEDICAL SOLUTIONS AG
  SUBSTANTIALLY EQUIVALENT 1
NANO-X AI , LTD.
  SUBSTANTIALLY EQUIVALENT 2
NANOXAI , LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUROLOGICA CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG
  SUBSTANTIALLY EQUIVALENT 2
NEUROLOGICA CORPORATION, A SUBSIDIARY OF SAMSUNG ELECTRONICS
  SUBSTANTIALLY EQUIVALENT 2
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 7
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS ULTRASOUND, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, LLC
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM SURGICAL SAS
  SUBSTANTIALLY EQUIVALENT 2
RIVERAIN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 9
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 38
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THIRONA BV
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
VIDA DIAGNOSTICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
XACT ROBOTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 4
ZEBRA MEDICAL VISION, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 233 238
2020 177 177
2021 261 261
2022 199 201
2023 310 311
2024 212 212
2025 222 222

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 256 261
Device Displays Incorrect Message 207 207
Application Program Problem 189 189
Patient Data Problem 98 98
Use of Device Problem 91 91
Device Operational Issue 66 66
Insufficient Information 63 63
Improper or Incorrect Procedure or Method 62 62
Computer Software Problem 56 56
Break 56 56
Connection Problem 48 48
Sharp Edges 45 45
No Apparent Adverse Event 41 41
Material Fragmentation 39 39
Application Network Problem 35 35
Communication or Transmission Problem 33 33
Unintended System Motion 31 31
Display or Visual Feedback Problem 30 30
Image Display Error/Artifact 30 30
Retraction Problem 27 27
Failure to Advance 25 25
Material Separation 24 24
Detachment of Device or Device Component 24 24
Defective Device 22 22
Application Program Freezes, Becomes Nonfunctional 21 21
Unintended Movement 20 20
Unexpected Shutdown 20 20
Output Problem 19 19
Mechanical Problem 17 17
Device Handling Problem 17 17
Appropriate Term/Code Not Available 15 15
No Display/Image 15 15
Device Sensing Problem 15 15
Electrical /Electronic Property Problem 14 14
Poor Quality Image 14 14
Unintended Electrical Shock 14 14
Radiofrequency Interference (RFI) 14 14
Therapeutic or Diagnostic Output Failure 14 14
Unintended Application Program Shut Down 13 13
Material Twisted/Bent 13 13
Failure to Power Up 11 11
Data Problem 10 10
Defective Component 10 10
Program or Algorithm Execution Problem 9 9
Device Dislodged or Dislocated 8 8
Erratic or Intermittent Display 8 8
Activation, Positioning or Separation Problem 8 8
Intermittent Program or Algorithm Execution 7 7
Program or Algorithm Execution Failure 7 7
Positioning Failure 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 651 651
Pneumothorax 147 148
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 146 146
Insufficient Information 111 111
No Code Available 103 103
Laceration(s) 63 63
No Known Impact Or Consequence To Patient 60 61
Radiation Exposure, Unintended 44 48
Unintended Radiation Exposure 39 39
Hemorrhage/Bleeding 36 36
No Consequences Or Impact To Patient 35 35
Abrasion 29 29
Bone Fracture(s) 27 27
Limb Fracture 21 21
Blood Loss 18 18
Injury 13 13
Bruise/Contusion 12 12
Death 12 12
Cardiac Arrest 12 12
No Patient Involvement 10 10
Electric Shock 10 10
Unspecified Tissue Injury 10 10
Foreign Body In Patient 9 9
Respiratory Failure 9 9
Head Injury 9 9
Patient Problem/Medical Problem 8 8
Skin Tears 8 8
Chest Pain 7 7
Headache 7 7
No Information 7 7
Crushing Injury 6 6
Dyspnea 5 5
Pain 5 5
Fever 5 5
Misdiagnosis 5 5
Hypersensitivity/Allergic reaction 4 4
Burning Sensation 4 4
Hemoptysis 4 4
Nausea 4 4
Fistula 3 3
Dizziness 3 3
Rash 3 3
Bronchial Hemorrhage 3 3
Not Applicable 3 3
Tachycardia 3 3
Fatigue 3 3
Hypoxia 3 3
Blurred Vision 3 3
Fall 2 2
Viral Infection 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Dec-09-2020
2 Canon Medical System, USA, INC. II Apr-10-2020
3 Carestream Health, Inc. II Apr-23-2019
4 Covidien, LLC II Jun-26-2023
5 FUJIFILM Healthcare Americas Corporation II Sep-16-2022
6 GE Healthcare (China) Co., Ltd. II Dec-04-2024
7 GE Healthcare, LLC II Apr-05-2022
8 GE Healthcare, LLC II Nov-24-2021
9 GE Healthcare, LLC II Jul-08-2021
10 GE Healthcare, LLC II Jul-08-2021
11 GE Healthcare, LLC II Jun-25-2021
12 GE Healthcare, LLC II Feb-17-2021
13 GE Healthcare, LLC II Dec-22-2020
14 GE Healthcare, LLC II Oct-29-2020
15 GE Healthcare, LLC II Jul-12-2019
16 GE Healthcare, LLC II May-03-2019
17 GE Healthcare, LLC II Feb-06-2019
18 GE Medical Systems, LLC II Mar-07-2025
19 Hitachi Medical Systems America Inc II Nov-01-2019
20 Imactis II Mar-16-2021
21 Imactis II Sep-15-2020
22 Imactis II Jan-22-2020
23 Mobius Imaging, LLC II Jan-09-2026
24 Mobius Imaging, LLC II Jan-17-2023
25 Mobius Imaging, LLC II Dec-06-2022
26 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
27 NeuroLogica Corporation II Jul-03-2023
28 NeuroLogica Corporation II Aug-07-2020
29 Neusoft Medical Systems Co., Ltd. II May-21-2019
30 Olympus Corporation of the Americas II Sep-29-2023
31 Olympus Corporation of the Americas II Jul-28-2023
32 Olympus Corporation of the Americas II Feb-07-2023
33 Orthoscan, Inc. II Dec-02-2024
34 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
35 PHILIPS MEDICAL SYSTEMS II Oct-27-2025
36 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
37 Philips Healthcare II Sep-30-2023
38 Philips Healthcare (Suzhou) Co., Ltd. II Jan-08-2026
39 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
40 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
41 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
42 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
43 Philips Medical Systems Nederland B.V. II Mar-12-2025
44 Philips North America, LLC II May-06-2020
45 Philips North America II Apr-09-2024
46 Philips North America II Jan-12-2024
47 Philips North America II Nov-16-2023
48 Philips North America II Nov-15-2023
49 Philips North America II Jul-28-2023
50 Philips North America II May-12-2023
51 Philips North America Llc II Dec-03-2025
52 Philips North America Llc II Sep-19-2025
53 Philips North America Llc II Jun-26-2025
54 Philips North America Llc II Apr-23-2025
55 Philips North America Llc II Dec-03-2024
56 Philips North America Llc II May-20-2024
57 Philips North America Llc II May-02-2024
58 Philips North America Llc II Jan-12-2024
59 Philips North America Llc II Dec-18-2023
60 Philips North America Llc II Nov-14-2023
61 Philips North America Llc II May-12-2023
62 Philips North America Llc II Nov-24-2021
63 Philips North America Llc II Aug-18-2021
64 Philips North America Llc II Jun-30-2021
65 Philips North America Llc II Jun-02-2021
66 Philips North America Llc II Mar-16-2021
67 QUANTUM SURGICAL SAS II Jun-09-2025
68 QUANTUM SURGICAL SAS II Oct-09-2024
69 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
70 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
71 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
72 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
73 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
74 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
75 Siemens Medical Solutions USA, Inc II Jan-20-2023
76 Siemens Medical Solutions USA, Inc II Aug-26-2022
77 Siemens Medical Solutions USA, Inc II Jul-06-2022
78 Siemens Medical Solutions USA, Inc II Apr-22-2022
79 Siemens Medical Solutions USA, Inc II Apr-20-2022
80 Siemens Medical Solutions USA, Inc II Jan-10-2022
81 Siemens Medical Solutions USA, Inc II Nov-24-2021
82 Siemens Medical Solutions USA, Inc II Sep-21-2021
83 Siemens Medical Solutions USA, Inc II Sep-10-2021
84 Siemens Medical Solutions USA, Inc II Mar-15-2021
85 Siemens Medical Solutions USA, Inc II Jan-09-2021
86 Siemens Medical Solutions USA, Inc II Sep-28-2020
87 Siemens Medical Solutions USA, Inc II Nov-21-2019
88 Siemens Medical Solutions USA, Inc II Nov-14-2019
89 Siemens Medical Solutions USA, Inc II Aug-30-2019
90 Siemens Medical Solutions USA, Inc II Aug-28-2019
91 Siemens Medical Solutions USA, Inc II Aug-14-2019
92 Siemens Medical Solutions USA, Inc II Jul-02-2019
93 Siemens Medical Solutions USA, Inc II Jul-02-2019
94 Siemens Medical Solutions USA, Inc II May-03-2019
95 Siemens Medical Solutions USA, Inc II Apr-09-2019
96 UIH Technologies LLC II Oct-21-2025
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