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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Super Search Devices@FDA
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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 3
BRAINOMIX LIMITED
  SUBSTANTIALLY EQUIVALENT 1
BUNKERHILL HEALTH
  SUBSTANTIALLY EQUIVALENT 2
BUNKERHILL, INC
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
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 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 7
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 1
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 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
RIVERAIN TECHNOLOGIES, INC.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 8
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 21
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 199 200
2023 310 310
2024 213 213
2025 20 20

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 189 189
Application Program Problem 151 151
Device Displays Incorrect Message 145 145
Patient Data Problem 66 66
Use of Device Problem 56 56
Insufficient Information 53 53
Improper or Incorrect Procedure or Method 47 47
Sharp Edges 44 44
Computer Software Problem 43 43
Device Operational Issue 42 42
Break 41 41
Connection Problem 40 40
Display or Visual Feedback Problem 28 28
Unintended System Motion 28 28
Application Network Problem 26 26
Retraction Problem 26 26
Material Separation 24 24
No Apparent Adverse Event 23 23
Material Fragmentation 22 22
Communication or Transmission Problem 22 22
Failure to Advance 19 19
Defective Device 18 18
Unexpected Shutdown 17 17
Application Program Freezes, Becomes Nonfunctional 17 17
Image Display Error/Artifact 17 17
Detachment of Device or Device Component 16 16
Output Problem 16 16
Device Sensing Problem 13 13
Electrical /Electronic Property Problem 13 13
Unintended Movement 13 13
Device Handling Problem 12 12
Therapeutic or Diagnostic Output Failure 11 11
Poor Quality Image 11 11
Material Twisted/Bent 11 11
No Display/Image 10 10
Failure to Power Up 10 10
Mechanical Problem 9 9
Radiofrequency Interference (RFI) 9 9
Appropriate Term/Code Not Available 8 8
Unintended Electrical Shock 8 8
Device Dislodged or Dislocated 7 7
Defective Component 7 7
Activation, Positioning or Separation Problem 7 7
Intermittent Program or Algorithm Execution 7 7
Unintended Application Program Shut Down 7 7
Program or Algorithm Execution Failure 7 7
Program or Algorithm Execution Problem 6 6
Erratic or Intermittent Display 5 5
Unintended Collision 5 5
Inadequate or Insufficient Training 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 519 519
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 126 126
Pneumothorax 102 102
Insufficient Information 97 97
No Code Available 51 51
Laceration(s) 44 44
Unintended Radiation Exposure 37 37
Hemorrhage/Bleeding 34 34
Bone Fracture(s) 23 23
Radiation Exposure, Unintended 21 21
Abrasion 21 21
No Known Impact Or Consequence To Patient 18 18
Limb Fracture 15 15
No Consequences Or Impact To Patient 13 13
Cardiac Arrest 11 11
Bruise/Contusion 10 10
Unspecified Tissue Injury 9 9
Foreign Body In Patient 8 8
Head Injury 8 8
Electric Shock 7 7
Death 6 6
Chest Pain 6 6
Skin Tears 6 6
Headache 5 5
Respiratory Failure 5 5
Blood Loss 4 4
No Patient Involvement 4 4
Hypersensitivity/Allergic reaction 4 4
Dyspnea 4 4
Crushing Injury 4 4
Burning Sensation 3 3
Blurred Vision 3 3
Rash 3 3
Pain 3 3
Nausea 3 3
Hemoptysis 3 3
Fatigue 3 3
Patient Problem/Medical Problem 3 3
Cough 3 3
Injury 3 3
No Information 3 3
Muscle/Tendon Damage 2 2
Dizziness 2 2
Vomiting 2 2
Confusion/ Disorientation 2 2
Tinnitus 2 2
Hip Fracture 2 2
Airway Obstruction 2 2
Tachycardia 2 2
Hemorrhagic Stroke 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 Imactis II Mar-16-2021
15 Imactis II Sep-15-2020
16 Imactis II Jan-22-2020
17 Mobius Imaging, LLC II Jan-17-2023
18 Mobius Imaging, LLC II Dec-06-2022
19 NeuroLogica Corporation II Jul-03-2023
20 NeuroLogica Corporation II Aug-07-2020
21 Olympus Corporation of the Americas II Sep-29-2023
22 Olympus Corporation of the Americas II Jul-28-2023
23 Olympus Corporation of the Americas II Feb-07-2023
24 Orthoscan, Inc. II Dec-02-2024
25 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
26 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
27 Philips Healthcare II Sep-30-2023
28 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
29 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
30 Philips North America, LLC II May-06-2020
31 Philips North America II Apr-09-2024
32 Philips North America II Jan-12-2024
33 Philips North America II Nov-16-2023
34 Philips North America II Nov-15-2023
35 Philips North America II Jul-28-2023
36 Philips North America II May-12-2023
37 Philips North America Llc II Dec-03-2024
38 Philips North America Llc II May-20-2024
39 Philips North America Llc II May-02-2024
40 Philips North America Llc II Jan-12-2024
41 Philips North America Llc II Dec-18-2023
42 Philips North America Llc II Nov-14-2023
43 Philips North America Llc II May-12-2023
44 Philips North America Llc II Nov-24-2021
45 Philips North America Llc II Aug-18-2021
46 Philips North America Llc II Jun-30-2021
47 Philips North America Llc II Jun-02-2021
48 Philips North America Llc II Mar-16-2021
49 QUANTUM SURGICAL SAS II Oct-09-2024
50 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
51 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
52 Shanghai United Imaging Healthcare Co., Ltd. II Jul-27-2020
53 Shanghai United Imaging Healthcare Co., Ltd. II Jul-20-2020
54 Shanghai United Imaging Healthcare Co., Ltd. II Jul-10-2020
55 Shanghai United Imaging Healthcare Co., Ltd. II Jun-30-2020
56 Siemens Medical Solutions USA, Inc II Jan-20-2023
57 Siemens Medical Solutions USA, Inc II Aug-26-2022
58 Siemens Medical Solutions USA, Inc II Jul-06-2022
59 Siemens Medical Solutions USA, Inc II Apr-22-2022
60 Siemens Medical Solutions USA, Inc II Apr-20-2022
61 Siemens Medical Solutions USA, Inc II Jan-10-2022
62 Siemens Medical Solutions USA, Inc II Nov-24-2021
63 Siemens Medical Solutions USA, Inc II Sep-21-2021
64 Siemens Medical Solutions USA, Inc II Sep-10-2021
65 Siemens Medical Solutions USA, Inc II Mar-15-2021
66 Siemens Medical Solutions USA, Inc II Jan-09-2021
67 Siemens Medical Solutions USA, Inc II Sep-28-2020
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