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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
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 2
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BUNKERHILL HEALTH
  SUBSTANTIALLY EQUIVALENT 1
BUNKERHILL, INC
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 17
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 1
CURVEBEAM, LLC
  SUBSTANTIALLY EQUIVALENT 1
FLUIDDA INC.
  SUBSTANTIALLY EQUIVALENT 1
FMI MEDICAL SYSTEMS INC.
  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 HANGWEI MEDICAL SYSTEMS, CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 7
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 8
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 5
GE MEDICAL SYSTEMS,LLC
  SUBSTANTIALLY EQUIVALENT 1
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
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 1
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 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 5
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 1
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
SHANGAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA INC.
  SUBSTANTIALLY EQUIVALENT 4
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 27
SIEMENS MEDICAL SOLUTIONS, USA, INC
  SUBSTANTIALLY EQUIVALENT 1
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 3
XACT ROBOTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 1
ZEBRA MEDICAL VISION LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2019 233 233
2020 177 177
2021 261 261
2022 199 200
2023 310 310
2024 171 171

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 227 227
Application Program Problem 162 162
Device Displays Incorrect Message 137 137
Use of Device Problem 77 77
Patient Data Problem 71 71
Device Operational Issue 59 59
Insufficient Information 55 55
Improper or Incorrect Procedure or Method 50 50
Break 48 48
Computer Software Problem 46 46
Sharp Edges 45 45
Connection Problem 42 42
Material Fragmentation 33 33
Unintended System Motion 31 31
Image Display Error/Artifact 29 29
Communication or Transmission Problem 27 27
Display or Visual Feedback Problem 27 27
Retraction Problem 27 27
Application Network Problem 25 25
Material Separation 24 24
No Apparent Adverse Event 21 21
Defective Device 21 21
Detachment of Device or Device Component 20 20
Application Program Freezes, Becomes Nonfunctional 20 20
Failure to Advance 17 17
Unexpected Shutdown 17 17
Unintended Movement 17 17
Mechanical Problem 16 16
Output Problem 16 16
No Display/Image 14 14
Device Handling Problem 14 14
Device Sensing Problem 13 13
Electrical /Electronic Property Problem 13 13
Therapeutic or Diagnostic Output Failure 12 12
Material Twisted/Bent 11 11
Unintended Electrical Shock 11 11
Radiofrequency Interference (RFI) 11 11
Failure to Power Up 10 10
Poor Quality Image 10 10
Defective Component 9 9
Program or Algorithm Execution Problem 8 8
Device Dislodged or Dislocated 8 8
Data Problem 8 8
Program or Algorithm Execution Failure 7 7
Intermittent Program or Algorithm Execution 7 7
Appropriate Term/Code Not Available 7 7
Activation, Positioning or Separation Problem 6 6
Inadequate or Insufficient Training 5 5
Corroded 5 5
Material Integrity Problem 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 480 480
Pneumothorax 127 127
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 120 120
No Code Available 103 103
Insufficient Information 92 92
No Known Impact Or Consequence To Patient 60 60
Laceration(s) 53 53
Radiation Exposure, Unintended 44 44
Unintended Radiation Exposure 37 37
No Consequences Or Impact To Patient 35 35
Hemorrhage/Bleeding 32 32
Bone Fracture(s) 25 25
Abrasion 25 25
Blood Loss 18 18
Injury 13 13
Limb Fracture 12 12
Death 12 12
Cardiac Arrest 11 11
Bruise/Contusion 11 11
Electric Shock 10 10
No Patient Involvement 10 10
Foreign Body In Patient 9 9
Unspecified Tissue Injury 9 9
Head Injury 9 9
Chest Pain 8 8
Skin Tears 8 8
Patient Problem/Medical Problem 8 8
Headache 7 7
No Information 7 7
Respiratory Failure 6 6
Misdiagnosis 5 5
Burning Sensation 4 4
Nausea 4 4
Hypersensitivity/Allergic reaction 4 4
Crushing Injury 4 4
Pain 4 4
Dyspnea 4 4
Tachycardia 3 3
Cough 3 3
Hypoxia 3 3
Hemoptysis 3 3
Dizziness 3 3
Not Applicable 3 3
Fatigue 3 3
Cyst(s) 2 2
Dry Eye(s) 2 2
Tinnitus 2 2
Muscle Weakness 2 2
Hemorrhagic Stroke 2 2
Blurred Vision 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, 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 Healthcare, LLC II Jul-12-2019
15 GE Healthcare, LLC II May-03-2019
16 GE Healthcare, LLC II Feb-06-2019
17 Hitachi Medical Systems America Inc II Nov-01-2019
18 Imactis II Mar-16-2021
19 Imactis II Sep-15-2020
20 Imactis II Jan-22-2020
21 Mobius Imaging, LLC II Jan-17-2023
22 Mobius Imaging, LLC II Dec-06-2022
23 NEUSOFT MEDICAL SYSTEMS IMP & EX II Feb-05-2019
24 NeuroLogica Corporation II Jul-03-2023
25 NeuroLogica Corporation II Aug-07-2020
26 Neusoft Medical Systems Co., Ltd. II May-21-2019
27 Olympus Corporation of the Americas II Sep-29-2023
28 Olympus Corporation of the Americas II Jul-28-2023
29 Olympus Corporation of the Americas II Feb-07-2023
30 Orthoscan, Inc. II Dec-02-2024
31 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
32 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
33 Philips Healthcare II Sep-30-2023
34 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
35 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
36 Philips Medical Systems (Cleveland) Inc II Aug-06-2019
37 Philips Medical Systems (Cleveland) Inc II Apr-13-2019
38 Philips North America, LLC II May-06-2020
39 Philips North America II Apr-09-2024
40 Philips North America II Jan-12-2024
41 Philips North America II Nov-16-2023
42 Philips North America II Nov-15-2023
43 Philips North America II Jul-28-2023
44 Philips North America II May-12-2023
45 Philips North America Llc II May-20-2024
46 Philips North America Llc II May-02-2024
47 Philips North America Llc II Jan-12-2024
48 Philips North America Llc II Dec-18-2023
49 Philips North America Llc II Nov-14-2023
50 Philips North America Llc II May-12-2023
51 Philips North America Llc II Nov-24-2021
52 Philips North America Llc II Aug-18-2021
53 Philips North America Llc II Jun-30-2021
54 Philips North America Llc II Jun-02-2021
55 Philips North America Llc II Mar-16-2021
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 Siemens Medical Solutions USA, Inc II Nov-21-2019
76 Siemens Medical Solutions USA, Inc II Nov-14-2019
77 Siemens Medical Solutions USA, Inc II Aug-30-2019
78 Siemens Medical Solutions USA, Inc II Aug-28-2019
79 Siemens Medical Solutions USA, Inc II Aug-14-2019
80 Siemens Medical Solutions USA, Inc II Jul-02-2019
81 Siemens Medical Solutions USA, Inc II Jul-02-2019
82 Siemens Medical Solutions USA, Inc II May-03-2019
83 Siemens Medical Solutions USA, Inc II Apr-09-2019
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