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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 15
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 2
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 7
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 8
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 CORP., A SAMSUNG COMPANY
  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 3
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 151 151

Device Problems MDRs with this Device Problem Events in those MDRs
Device Displays Incorrect Message 222 222
Adverse Event Without Identified Device or Use Problem 183 184
Application Program Problem 142 142
Patient Data Problem 81 81
Use of Device Problem 64 64
Insufficient Device Problem Information 59 59
Improper or Incorrect Procedure or Method 54 54
Computer Software Problem 47 47
Connection Problem 46 46
Sharp Edges 41 41
No Apparent Adverse Event 41 41
Device Operational Issue 35 35
Break 29 29
Failure to Advance 29 29
Communication or Transmission Problem 26 26
Appropriate Device Problem Term/Code Not Available 26 26
Retraction Problem 25 25
Material Fragmentation 25 25
Application Network Problem 23 23
Display or Visual Feedback Problem 22 22
Material Separation 21 21
Unintended System Motion 21 21
Device Handling Problem 19 19
Detachment of Device or Device Component 19 19
Image Display Error/Artifact 17 17
Unexpected Shutdown 15 15
Application Program Freezes or Fails to Launch 13 13
Mechanical Problem 13 13
Unintended Electrical Shock 12 12
Material Twisted/Bent 11 11
Device Sensing Problem 11 11
Output Problem 11 11
Electrical /Electronic Property Problem 11 11
Radiofrequency Interference (RFI) 11 11
Unintended Application Program Shut Down 10 10
Unintended Movement 9 9
Poor Quality Image 8 8
Program or Algorithm Execution Problem 8 8
Device Dislodged or Dislocated 7 7
Program or Algorithm Execution Failure 7 7
Radiation Overexposure 7 7
Intermittent Program or Algorithm Execution 7 7
Data Problem 7 7
Erratic or Intermittent Display 6 6
Radiation Output Failure 6 6
Defective Device 5 5
Inadequate or Insufficient Training 5 5
Corroded 5 5
No Display/Image 5 5
Failure to Power Up 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 746 746
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 146 146
Insufficient Information 111 111
Pneumothorax 108 109
Laceration(s) 46 46
Hemorrhage/Blood Loss/Bleeding 39 39
Unintended Radiation Exposure 37 37
Abrasion 23 23
Limb Fracture 21 21
Bone Fracture(s) 19 19
Cardiac Arrest 12 12
Bruise/Contusion 11 11
Foreign Body In Patient 10 10
Unspecified Tissue Injury 10 10
Head Injury 7 7
Skin Tears 7 7
Electric Shock 7 7
Pain 6 6
Crushing Injury 6 6
Dyspnea 5 5
Respiratory Failure 5 5
Radiation Exposure, Unintended 4 4
Hypersensitivity/Allergic reaction 4 4
Headache 4 4
Hemoptysis 4 4
Fever 4 4
Limb Pain 3 3
Bronchial Hemorrhage 3 3
Hip Fracture 3 3
Chest Pain 3 3
Burning Sensation 3 3
Rash 3 3
Nervous System Injury 3 3
Fistula 3 3
Swelling/ Edema 2 2
Blurred Vision 2 2
Cough 2 2
Muscle/Tendon Damage 2 2
Fall 2 2
Numbness 2 2
Vomiting 2 2
Pleural Effusion 2 2
Erythema 2 2
Tinnitus 2 2
Airway Obstruction 2 2
Hepatitis 2 2
Burn(s) 2 2
Hemorrhagic Stroke 2 2
Fatigue 2 2
Cognitive Changes 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 May-08-2026
11 GE Medical Systems, LLC II Mar-20-2026
12 GE Medical Systems, LLC II Mar-07-2025
13 Imactis II Mar-16-2021
14 Mobius Imaging, LLC II Jan-09-2026
15 Mobius Imaging, LLC II Jan-17-2023
16 Mobius Imaging, LLC II Dec-06-2022
17 NeuroLogica Corporation II Jul-03-2023
18 Olympus Corporation of the Americas II Sep-29-2023
19 Olympus Corporation of the Americas II Jul-28-2023
20 Olympus Corporation of the Americas II Feb-07-2023
21 Orthoscan, Inc. II Dec-02-2024
22 PHILIPS HEADQUARTERS CAMBRIDGE II May-23-2023
23 PHILIPS MEDICAL SYSTEMS II Jul-27-2026
24 PHILIPS MEDICAL SYSTEMS II Apr-16-2026
25 PHILIPS MEDICAL SYSTEMS II Oct-27-2025
26 PHILIPS MEDICAL SYSTEMS II Feb-08-2024
27 Philips Healthcare II Sep-30-2023
28 Philips Healthcare (Suzhou) Co., Ltd. II Aug-21-2026
29 Philips Healthcare (Suzhou) Co., Ltd. II Jan-08-2026
30 Philips Healthcare (Suzhou) Co., Ltd. II Jan-05-2024
31 Philips Healthcare (Suzhou) Co., Ltd. II Mar-17-2021
32 Philips Medical Systems Nederland B.V. II Mar-12-2025
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 Sep-01-2026
40 Philips North America Llc II Feb-06-2026
41 Philips North America Llc II Dec-03-2025
42 Philips North America Llc II Sep-19-2025
43 Philips North America Llc II Jun-26-2025
44 Philips North America Llc II Apr-23-2025
45 Philips North America Llc II Dec-03-2024
46 Philips North America Llc II May-20-2024
47 Philips North America Llc II May-02-2024
48 Philips North America Llc II Jan-12-2024
49 Philips North America Llc II Dec-18-2023
50 Philips North America Llc II Nov-14-2023
51 Philips North America Llc II May-12-2023
52 Philips North America Llc II Nov-24-2021
53 Philips North America Llc II Aug-18-2021
54 Philips North America Llc II Jun-30-2021
55 Philips North America Llc II Jun-02-2021
56 Philips North America Llc II Mar-16-2021
57 QUANTUM SURGICAL SAS II Jun-09-2025
58 QUANTUM SURGICAL SAS II Oct-09-2024
59 Siemens Medical Solutions USA, Inc II Feb-03-2026
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 UIH Technologies LLC II Oct-21-2025
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