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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 3
BUNKERHILL, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL INFORMATICS, INC.
  SUBSTANTIALLY EQUIVALENT 3
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 13
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 5
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 6
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 6
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
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 5
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 4
PHILIPS MEDICAL SYSTEMS TECHNOLOGIES, LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 7
SIEMENS HEALTHCARE GMBH
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS U.S.A.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 24
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

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 189 189
Adverse Event Without Identified Device or Use Problem 180 181
Application Program Problem 138 138
Patient Data Problem 73 73
Use of Device Problem 57 57
Insufficient Information 57 57
Improper or Incorrect Procedure or Method 49 49
Computer Software Problem 44 44
Sharp Edges 43 43
Connection Problem 43 43
No Apparent Adverse Event 41 41
Break 41 41
Device Operational Issue 32 32
Retraction Problem 26 26
Communication or Transmission Problem 26 26
Failure to Advance 25 25
Material Fragmentation 24 24
Material Separation 23 23
Display or Visual Feedback Problem 23 23
Application Network Problem 23 23
Unintended System Motion 22 22
Unexpected Shutdown 18 18
Detachment of Device or Device Component 17 17
Output Problem 17 17
Application Program Freezes, Becomes Nonfunctional 16 16
Appropriate Term/Code Not Available 15 15
Image Display Error/Artifact 14 14
Device Handling Problem 14 14
Material Twisted/Bent 12 12
Device Sensing Problem 12 12
Defective Device 12 12
Electrical /Electronic Property Problem 12 12
Radiofrequency Interference (RFI) 11 11
Poor Quality Image 11 11
Unintended Electrical Shock 11 11
Unintended Movement 10 10
Unintended Application Program Shut Down 10 10
No Display/Image 9 9
Therapeutic or Diagnostic Output Failure 9 9
Mechanical Problem 8 8
Program or Algorithm Execution Problem 7 7
Device Dislodged or Dislocated 7 7
Erratic or Intermittent Display 7 7
Activation, Positioning or Separation Problem 7 7
Program or Algorithm Execution Failure 7 7
Intermittent Program or Algorithm Execution 7 7
Defective Component 7 7
Data Problem 7 7
Failure to Power Up 6 6
Radiation Output Failure 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 636 636
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 140 140
Insufficient Information 104 104
Pneumothorax 102 103
Laceration(s) 41 41
Hemorrhage/Bleeding 36 36
Unintended Radiation Exposure 35 35
Abrasion 20 20
Limb Fracture 19 19
Bone Fracture(s) 19 19
Cardiac Arrest 11 11
Bruise/Contusion 10 10
Unspecified Tissue Injury 9 9
Foreign Body In Patient 8 8
Electric Shock 7 7
Head Injury 7 7
Skin Tears 6 6
Dyspnea 5 5
Crushing Injury 5 5
Respiratory Failure 5 5
Pain 4 4
Hypersensitivity/Allergic reaction 4 4
Fever 4 4
Headache 4 4
Hemoptysis 4 4
Chest Pain 3 3
Rash 3 3
Bronchial Hemorrhage 3 3
Radiation Exposure, Unintended 3 3
Fistula 3 3
Dizziness 2 2
Fall 2 2
Airway Obstruction 2 2
Muscle Weakness 2 2
Muscle/Tendon Damage 2 2
Tinnitus 2 2
Unspecified Gastrointestinal Problem 2 2
Respiratory Arrest 2 2
Hemorrhagic Stroke 2 2
Vomiting 2 2
Pleural Effusion 2 2
Nausea 2 2
Blurred Vision 2 2
Fatigue 2 2
Erythema 2 2
Hip Fracture 2 2
Cough 2 2
Hepatitis 2 2
Burning Sensation 2 2
Skin Burning Sensation 1 1

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