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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 1
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 2
BUNKERHILL, INC
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 15
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 2
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
MEVIS MEDICAL SOLUTIONS AG
  SUBSTANTIALLY EQUIVALENT 1
NANO-X AI LTD.
  SUBSTANTIALLY EQUIVALENT 2
NANOXAI LTD.
  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 3
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 22
SIEMENS MEDICAL SOLUTIONS, USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOULTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
THIRONA BV
  SUBSTANTIALLY EQUIVALENT 1
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 199 199
2023 310 310
2024 213 213
2025 103 103

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 194 194
Device Displays Incorrect Message 174 174
Application Program Problem 166 166
Patient Data Problem 78 78
Use of Device Problem 60 60
Insufficient Information 54 54
Improper or Incorrect Procedure or Method 48 48
Device Operational Issue 46 46
Break 45 45
Sharp Edges 44 44
Computer Software Problem 44 44
Connection Problem 41 41
No Apparent Adverse Event 32 32
Display or Visual Feedback Problem 28 28
Unintended System Motion 28 28
Application Network Problem 27 27
Retraction Problem 26 26
Material Separation 24 24
Communication or Transmission Problem 24 24
Material Fragmentation 23 23
Failure to Advance 23 23
Unexpected Shutdown 18 18
Defective Device 18 18
Detachment of Device or Device Component 17 17
Output Problem 17 17
Application Program Freezes, Becomes Nonfunctional 17 17
Image Display Error/Artifact 17 17
Device Sensing Problem 14 14
Poor Quality Image 14 14
Material Twisted/Bent 13 13
Electrical /Electronic Property Problem 13 13
Unintended Movement 13 13
Radiofrequency Interference (RFI) 12 12
Device Handling Problem 12 12
Therapeutic or Diagnostic Output Failure 12 12
Failure to Power Up 11 11
Unintended Application Program Shut Down 11 11
Unintended Electrical Shock 11 11
Appropriate Term/Code Not Available 10 10
No Display/Image 10 10
Mechanical Problem 9 9
Activation, Positioning or Separation Problem 8 8
Device Dislodged or Dislocated 7 7
Program or Algorithm Execution Failure 7 7
Defective Component 7 7
Intermittent Program or Algorithm Execution 7 7
Program or Algorithm Execution Problem 7 7
Erratic or Intermittent Display 6 6
Positioning Failure 6 6
Inadequate or Insufficient Training 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 576 576
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 137 137
Pneumothorax 104 104
Insufficient Information 102 102
No Code Available 51 51
Laceration(s) 44 44
Unintended Radiation Exposure 38 38
Hemorrhage/Bleeding 35 35
Bone Fracture(s) 23 23
Abrasion 21 21
Radiation Exposure, Unintended 21 21
No Known Impact Or Consequence To Patient 18 18
Limb Fracture 16 16
No Consequences Or Impact To Patient 13 13
Cardiac Arrest 12 12
Bruise/Contusion 10 10
Unspecified Tissue Injury 9 9
Head Injury 8 8
Foreign Body In Patient 8 8
Electric Shock 7 7
Skin Tears 6 6
Death 6 6
Headache 5 5
Chest Pain 5 5
Respiratory Failure 5 5
Dyspnea 5 5
No Patient Involvement 4 4
Hypersensitivity/Allergic reaction 4 4
Hemoptysis 4 4
Pain 4 4
Crushing Injury 4 4
Blood Loss 4 4
Bronchial Hemorrhage 3 3
Nausea 3 3
Fatigue 3 3
Injury 3 3
Burning Sensation 3 3
Rash 3 3
No Information 3 3
Blurred Vision 3 3
Patient Problem/Medical Problem 3 3
Muscle/Tendon Damage 2 2
Oversedation 2 2
Tachycardia 2 2
Cough 2 2
Erythema 2 2
Pleural Effusion 2 2
Vomiting 2 2
Confusion/ Disorientation 2 2
Fall 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 Feb-08-2024
28 Philips Healthcare II Sep-30-2023
29 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
30 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
31 Philips Medical Systems Nederland B.V. II Mar-12-2025
32 Philips North America, LLC II May-06-2020
33 Philips North America II Apr-09-2024
34 Philips North America II Jan-12-2024
35 Philips North America II Nov-16-2023
36 Philips North America II Nov-15-2023
37 Philips North America II Jul-28-2023
38 Philips North America II May-12-2023
39 Philips North America Llc II Apr-23-2025
40 Philips North America Llc II Dec-03-2024
41 Philips North America Llc II May-20-2024
42 Philips North America Llc II May-02-2024
43 Philips North America Llc II Jan-12-2024
44 Philips North America Llc II Dec-18-2023
45 Philips North America Llc II Nov-14-2023
46 Philips North America Llc II May-12-2023
47 Philips North America Llc II Nov-24-2021
48 Philips North America Llc II Aug-18-2021
49 Philips North America Llc II Jun-30-2021
50 Philips North America Llc II Jun-02-2021
51 Philips North America Llc II Mar-16-2021
52 QUANTUM SURGICAL SAS II Jun-09-2025
53 QUANTUM SURGICAL SAS II Oct-09-2024
54 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
55 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
56 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
57 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
58 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
59 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
60 Siemens Medical Solutions USA, Inc II Jan-20-2023
61 Siemens Medical Solutions USA, Inc II Aug-26-2022
62 Siemens Medical Solutions USA, Inc II Jul-06-2022
63 Siemens Medical Solutions USA, Inc II Apr-22-2022
64 Siemens Medical Solutions USA, Inc II Apr-20-2022
65 Siemens Medical Solutions USA, Inc II Jan-10-2022
66 Siemens Medical Solutions USA, Inc II Nov-24-2021
67 Siemens Medical Solutions USA, Inc II Sep-21-2021
68 Siemens Medical Solutions USA, Inc II Sep-10-2021
69 Siemens Medical Solutions USA, Inc II Mar-15-2021
70 Siemens Medical Solutions USA, Inc II Jan-09-2021
71 Siemens Medical Solutions USA, Inc II Sep-28-2020
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