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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 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 16
CASCINATION AG
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 3
CURVEBEAM LLC
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
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 1
GE HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 8
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS,LLC
  SUBSTANTIALLY EQUIVALENT 1
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
HITACHI HEALTHCARE AMERICAS
  SUBSTANTIALLY EQUIVALENT 1
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 1
NEUROLOGICA CORPORATION,
  SUBSTANTIALLY EQUIVALENT 2
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 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS NEDERLAND, B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES LTD.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND LLC
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS ULTRASOUND, INC
  SUBSTANTIALLY EQUIVALENT 1
PULMONX CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
QUANTUM SURGICAL SAS
  SUBSTANTIALLY EQUIVALENT 2
RIVERAIN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 25
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
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 2
XACT ROBOTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 177 177
2021 261 261
2022 199 201
2023 310 310
2024 212 212
2025 190 190

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 207 207
Device Displays Incorrect Message 189 189
Application Program Problem 172 172
Patient Data Problem 83 83
Use of Device Problem 65 65
Insufficient Information 55 55
Improper or Incorrect Procedure or Method 54 54
Device Operational Issue 48 48
Computer Software Problem 47 47
Connection Problem 46 46
Break 46 46
Sharp Edges 44 44
No Apparent Adverse Event 41 41
Application Network Problem 30 30
Display or Visual Feedback Problem 29 29
Unintended System Motion 28 28
Communication or Transmission Problem 27 27
Material Fragmentation 26 26
Retraction Problem 26 26
Failure to Advance 25 25
Material Separation 24 24
Detachment of Device or Device Component 20 20
Defective Device 19 19
Unexpected Shutdown 19 19
Application Program Freezes, Becomes Nonfunctional 18 18
Output Problem 18 18
Image Display Error/Artifact 18 18
Unintended Movement 15 15
Device Handling Problem 14 14
Poor Quality Image 14 14
Device Sensing Problem 14 14
Appropriate Term/Code Not Available 13 13
Material Twisted/Bent 13 13
Electrical /Electronic Property Problem 13 13
Therapeutic or Diagnostic Output Failure 13 13
Unintended Application Program Shut Down 13 13
Radiofrequency Interference (RFI) 12 12
Unintended Electrical Shock 11 11
Failure to Power Up 11 11
Mechanical Problem 10 10
No Display/Image 10 10
Erratic or Intermittent Display 8 8
Activation, Positioning or Separation Problem 8 8
Device Dislodged or Dislocated 7 7
Data Problem 7 7
Intermittent Program or Algorithm Execution 7 7
Program or Algorithm Execution Failure 7 7
Defective Component 7 7
Program or Algorithm Execution Problem 7 7
Use of Incorrect Control/Treatment Settings 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 629 629
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 143 143
Pneumothorax 114 114
Insufficient Information 110 110
No Code Available 51 51
Laceration(s) 47 47
Unintended Radiation Exposure 39 39
Hemorrhage/Bleeding 36 36
Abrasion 24 24
Bone Fracture(s) 23 23
Limb Fracture 21 21
Radiation Exposure, Unintended 21 21
No Known Impact Or Consequence To Patient 18 18
No Consequences Or Impact To Patient 13 13
Cardiac Arrest 12 12
Bruise/Contusion 11 11
Unspecified Tissue Injury 10 10
Head Injury 8 8
Foreign Body In Patient 8 8
Electric Shock 7 7
Skin Tears 6 6
Crushing Injury 6 6
Death 6 6
Chest Pain 5 5
Respiratory Failure 5 5
Headache 5 5
Dyspnea 5 5
Fever 4 4
No Patient Involvement 4 4
Hemoptysis 4 4
Hypersensitivity/Allergic reaction 4 4
Pain 4 4
Blood Loss 4 4
Nausea 3 3
Bronchial Hemorrhage 3 3
Fatigue 3 3
Injury 3 3
Burning Sensation 3 3
Rash 3 3
No Information 3 3
Fistula 3 3
Blurred Vision 3 3
Patient Problem/Medical Problem 3 3
Erythema 2 2
Tachycardia 2 2
Pleural Effusion 2 2
Oversedation 2 2
Cough 2 2
Vomiting 2 2
Muscle/Tendon Damage 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 Covidien, LLC II Jun-26-2023
4 FUJIFILM Healthcare Americas Corporation II Sep-16-2022
5 GE Healthcare (China) Co., Ltd. II Dec-04-2024
6 GE Healthcare, LLC II Apr-05-2022
7 GE Healthcare, LLC II Nov-24-2021
8 GE Healthcare, LLC II Jul-08-2021
9 GE Healthcare, LLC II Jul-08-2021
10 GE Healthcare, LLC II Jun-25-2021
11 GE Healthcare, LLC II Feb-17-2021
12 GE Healthcare, LLC II Dec-22-2020
13 GE Healthcare, LLC II Oct-29-2020
14 GE Medical Systems, LLC II Mar-07-2025
15 Imactis II Mar-16-2021
16 Imactis II Sep-15-2020
17 Imactis II Jan-22-2020
18 Mobius Imaging, LLC II Jan-17-2023
19 Mobius Imaging, LLC II Dec-06-2022
20 NeuroLogica Corporation II Jul-03-2023
21 NeuroLogica Corporation II Aug-07-2020
22 Olympus Corporation of the Americas II Sep-29-2023
23 Olympus Corporation of the Americas II Jul-28-2023
24 Olympus Corporation of the Americas II Feb-07-2023
25 Orthoscan, Inc. II Dec-02-2024
26 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
27 PHILIPS MEDICAL SYSTEMS II Oct-27-2025
28 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
29 Philips Healthcare II Sep-30-2023
30 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
31 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
32 Philips Medical Systems Nederland B.V. II Mar-12-2025
33 Philips North America, LLC II May-06-2020
34 Philips North America II Apr-09-2024
35 Philips North America II Jan-12-2024
36 Philips North America II Nov-16-2023
37 Philips North America II Nov-15-2023
38 Philips North America II Jul-28-2023
39 Philips North America II May-12-2023
40 Philips North America Llc II Sep-19-2025
41 Philips North America Llc II Jun-26-2025
42 Philips North America Llc II Apr-23-2025
43 Philips North America Llc II Dec-03-2024
44 Philips North America Llc II May-20-2024
45 Philips North America Llc II May-02-2024
46 Philips North America Llc II Jan-12-2024
47 Philips North America Llc II Dec-18-2023
48 Philips North America Llc II Nov-14-2023
49 Philips North America Llc II May-12-2023
50 Philips North America Llc II Nov-24-2021
51 Philips North America Llc II Aug-18-2021
52 Philips North America Llc II Jun-30-2021
53 Philips North America Llc II Jun-02-2021
54 Philips North America Llc II Mar-16-2021
55 QUANTUM SURGICAL SAS II Jun-09-2025
56 QUANTUM SURGICAL SAS II Oct-09-2024
57 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
58 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
59 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
60 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
61 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
62 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
63 Siemens Medical Solutions USA, Inc II Jan-20-2023
64 Siemens Medical Solutions USA, Inc II Aug-26-2022
65 Siemens Medical Solutions USA, Inc II Jul-06-2022
66 Siemens Medical Solutions USA, Inc II Apr-22-2022
67 Siemens Medical Solutions USA, Inc II Apr-20-2022
68 Siemens Medical Solutions USA, Inc II Jan-10-2022
69 Siemens Medical Solutions USA, Inc II Nov-24-2021
70 Siemens Medical Solutions USA, Inc II Sep-21-2021
71 Siemens Medical Solutions USA, Inc II Sep-10-2021
72 Siemens Medical Solutions USA, Inc II Mar-15-2021
73 Siemens Medical Solutions USA, Inc II Jan-09-2021
74 Siemens Medical Solutions USA, Inc II Sep-28-2020
75 UIH Technologies LLC II Oct-21-2025
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