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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
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 5
BUNKERHILL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 14
CASCINATION AG
  SUBSTANTIALLY EQUIVALENT 1
CEFLA S.C.
  SUBSTANTIALLY EQUIVALENT 1
CLEAR GUIDE MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
CURVEBEAM, LLC
  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 HEALTHCARE JAPAN CORPORATION
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 7
HANGZHOU DEEPWISE & LEAGUE OF PHD TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
IMBIO, INC.
  SUBSTANTIALLY EQUIVALENT 1
ISYS MEDIZINTECHNIK GMBH
  SUBSTANTIALLY EQUIVALENT 2
LEO CANCER CARE
  SUBSTANTIALLY EQUIVALENT 1
MARS BIOIMAGING , LTD.
  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 1
NEUSOFT MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUWAVE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS HEALTHCARE (SUZHOU) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 5
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES , LTD.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS ULTRASOUND, LLC
  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 25
THIRONA BV
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 2
XACT ROBOTICS, LTD.
  SUBSTANTIALLY EQUIVALENT 2
ZEBRA MEDICAL VISION, LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 261 261
2022 199 201
2023 310 311
2024 212 212
2025 222 222
2026 46 46

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 203 203
Adverse Event Without Identified Device or Use Problem 182 183
Application Program Problem 141 141
Patient Data Problem 75 75
Use of Device Problem 59 59
Insufficient Information 59 59
Improper or Incorrect Procedure or Method 50 50
Computer Software Problem 47 47
Connection Problem 45 45
Sharp Edges 43 43
Break 41 41
No Apparent Adverse Event 41 41
Device Operational Issue 34 34
Failure to Advance 28 28
Communication or Transmission Problem 27 27
Retraction Problem 26 26
Material Fragmentation 25 25
Display or Visual Feedback Problem 23 23
Material Separation 23 23
Application Network Problem 23 23
Unintended System Motion 22 22
Appropriate Term/Code Not Available 20 20
Detachment of Device or Device Component 19 19
Unexpected Shutdown 18 18
Output Problem 17 17
Application Program Freezes, Becomes Nonfunctional 16 16
Image Display Error/Artifact 16 16
Device Handling Problem 14 14
Electrical /Electronic Property Problem 13 13
Material Twisted/Bent 12 12
Defective Device 12 12
Device Sensing Problem 12 12
Poor Quality Image 12 12
Unintended Movement 11 11
Unintended Electrical Shock 11 11
Radiofrequency Interference (RFI) 11 11
Unintended Application Program Shut Down 10 10
Mechanical Problem 9 9
No Display/Image 9 9
Therapeutic or Diagnostic Output Failure 9 9
Erratic or Intermittent Display 7 7
Device Dislodged or Dislocated 7 7
Program or Algorithm Execution Failure 7 7
Defective Component 7 7
Intermittent Program or Algorithm Execution 7 7
Activation, Positioning or Separation Problem 7 7
Data Problem 7 7
Program or Algorithm Execution Problem 7 7
Radiation Overexposure 6 6
Failure to Power Up 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 668 668
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 144 144
Insufficient Information 106 106
Pneumothorax 103 104
Laceration(s) 41 41
Hemorrhage/Bleeding 38 38
Unintended Radiation Exposure 35 35
Abrasion 20 20
Limb Fracture 19 19
Bone Fracture(s) 19 19
Cardiac Arrest 12 12
Bruise/Contusion 10 10
Foreign Body In Patient 10 10
Unspecified Tissue Injury 10 10
Electric Shock 7 7
Head Injury 7 7
Crushing Injury 6 6
Pain 6 6
Skin Tears 6 6
Dyspnea 5 5
Respiratory Failure 5 5
Headache 4 4
Hemoptysis 4 4
Fever 4 4
Radiation Exposure, Unintended 4 4
Hypersensitivity/Allergic reaction 4 4
Rash 3 3
Burning Sensation 3 3
Bronchial Hemorrhage 3 3
Chest Pain 3 3
Fistula 3 3
Hepatitis 2 2
Cough 2 2
Swelling/ Edema 2 2
Vomiting 2 2
Blurred Vision 2 2
Numbness 2 2
Muscle/Tendon Damage 2 2
Erythema 2 2
Pleural Effusion 2 2
Hemorrhagic Stroke 2 2
Fall 2 2
Muscle Weakness 2 2
Tinnitus 2 2
Dizziness 2 2
Sepsis 2 2
Unspecified Gastrointestinal Problem 2 2
Airway Obstruction 2 2
Nausea 2 2
Fatigue 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Covidien, LLC II Jun-26-2023
2 FUJIFILM Healthcare Americas Corporation II Sep-16-2022
3 GE Healthcare (China) Co., Ltd. II Dec-04-2024
4 GE Healthcare, LLC II Apr-05-2022
5 GE Healthcare, LLC II Nov-24-2021
6 GE Healthcare, LLC II Jul-08-2021
7 GE Healthcare, LLC II Jul-08-2021
8 GE Healthcare, LLC II Jun-25-2021
9 GE Healthcare, LLC II Feb-17-2021
10 GE Medical Systems, LLC II Mar-20-2026
11 GE Medical Systems, LLC II Mar-07-2025
12 Imactis II Mar-16-2021
13 Mobius Imaging, LLC II Jan-09-2026
14 Mobius Imaging, LLC II Jan-17-2023
15 Mobius Imaging, LLC II Dec-06-2022
16 NeuroLogica Corporation II Jul-03-2023
17 Olympus Corporation of the Americas II Sep-29-2023
18 Olympus Corporation of the Americas II Jul-28-2023
19 Olympus Corporation of the Americas II Feb-07-2023
20 Orthoscan, Inc. II Dec-02-2024
21 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
22 PHILIPS MEDICAL SYSTEMS II Apr-16-2026
23 PHILIPS MEDICAL SYSTEMS II Oct-27-2025
24 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
25 Philips Healthcare II Sep-30-2023
26 Philips Healthcare (Suzhou) Co., Ltd. II Jan-08-2026
27 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
28 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
29 Philips Medical Systems Nederland B.V. II Mar-12-2025
30 Philips North America II Apr-09-2024
31 Philips North America II Jan-12-2024
32 Philips North America II Nov-16-2023
33 Philips North America II Nov-15-2023
34 Philips North America II Jul-28-2023
35 Philips North America II May-12-2023
36 Philips North America Llc II Feb-06-2026
37 Philips North America Llc II Dec-03-2025
38 Philips North America Llc II Sep-19-2025
39 Philips North America Llc II Jun-26-2025
40 Philips North America Llc II Apr-23-2025
41 Philips North America Llc II Dec-03-2024
42 Philips North America Llc II May-20-2024
43 Philips North America Llc II May-02-2024
44 Philips North America Llc II Jan-12-2024
45 Philips North America Llc II Dec-18-2023
46 Philips North America Llc II Nov-14-2023
47 Philips North America Llc II May-12-2023
48 Philips North America Llc II Nov-24-2021
49 Philips North America Llc II Aug-18-2021
50 Philips North America Llc II Jun-30-2021
51 Philips North America Llc II Jun-02-2021
52 Philips North America Llc II Mar-16-2021
53 QUANTUM SURGICAL SAS II Jun-09-2025
54 QUANTUM SURGICAL SAS II Oct-09-2024
55 Siemens Medical Solutions USA, Inc II Feb-03-2026
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 UIH Technologies LLC II Oct-21-2025
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