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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, tomography, computed, emission
Regulation Description Emission computed tomography system.
Product CodeKPS
Regulation Number 892.1200
Device Class 2


Premarket Reviews
ManufacturerDecision
BRACCO DIAGNOSTICS INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
CARDIOVASCULAR IMAGING TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
COMBINOSTICS OY
  SUBSTANTIALLY EQUIVALENT 1
EVER FORTUNE.AI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 4
GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 3
GE MEDICAL SYSTEMS, LLC.
  SUBSTANTIALLY EQUIVALENT 1
GENERAL EQUIPMENT FOR MEDICAL IMAGING, S.A.
  SUBSTANTIALLY EQUIVALENT 1
HERMES MEDICAL SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 3
MCGOVERN MEDICAL SCHOOL
  SUBSTANTIALLY EQUIVALENT 2
MIEGMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 2
POSITRIGO AG
  SUBSTANTIALLY EQUIVALENT 1
PRESCIENT IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIALIS INC.
  SUBSTANTIALLY EQUIVALENT 1
RAYSOLUTION HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 6
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 4
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS HEALTHINEERS
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 9
SIRTEX MEDICAL US HOLDINGS INC.
  SUBSTANTIALLY EQUIVALENT 1
SPECTRUM DYNAMICS MEDICAL LTD
  SUBSTANTIALLY EQUIVALENT 1
SUBTLE MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SYNTERMED
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 22 22
2021 10 10
2022 15 15
2023 22 22
2024 23 23
2025 22 22

Device Problems MDRs with this Device Problem Events in those MDRs
Mechanical Problem 22 22
Unintended System Motion 20 20
Improper or Incorrect Procedure or Method 14 14
Use of Device Problem 13 13
Fail-Safe Problem 8 8
Adverse Event Without Identified Device or Use Problem 6 6
Difficult to Open or Close 5 5
Insufficient Information 4 4
No Apparent Adverse Event 4 4
Unintended Collision 4 4
Leak/Splash 2 2
Smoking 2 2
Therapeutic or Diagnostic Output Failure 2 2
Device Handling Problem 2 2
Detachment of Device or Device Component 2 2
Device Dislodged or Dislocated 2 2
Loss of Data 2 2
Signal Artifact/Noise 1 1
Radiation Output Problem 1 1
Malposition of Device 1 1
Output Problem 1 1
Poor Quality Image 1 1
Application Program Version or Upgrade Problem 1 1
Device Fell 1 1
Structural Problem 1 1
Use of Incorrect Control/Treatment Settings 1 1
Power Problem 1 1
Protective Measures Problem 1 1
Device Displays Incorrect Message 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 55 55
Laceration(s) 15 15
Bone Fracture(s) 10 10
No Patient Involvement 9 9
Insufficient Information 7 7
No Consequences Or Impact To Patient 6 6
Head Injury 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 3 3
Fall 3 3
Crushing Injury 2 2
No Known Impact Or Consequence To Patient 2 2
Pain 2 2
Damage to Ligament(s) 1 1
Patient Problem/Medical Problem 1 1
Stroke/CVA 1 1
Hypersensitivity/Allergic reaction 1 1
Hip Fracture 1 1
Unspecified Gastrointestinal Problem 1 1
Misdiagnosis 1 1
Hematoma 1 1
Muscle Weakness 1 1
Cramp(s) /Muscle Spasm(s) 1 1
Hernia 1 1
Limb Fracture 1 1
Radiation Burn 1 1
Hemorrhage/Bleeding 1 1
Bruise/Contusion 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Nov-01-2024
2 Canon Medical System, USA, INC. II Oct-19-2021
3 GE Healthcare, LLC II May-11-2021
4 GE Healthcare, LLC II Jan-13-2021
5 GE Healthcare, LLC II Sep-21-2020
6 GE Healthcare, LLC II Jun-03-2020
7 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING II Jan-10-2025
8 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING II Jun-07-2024
9 GE MEDICAL SYSTEMS ISRAEL, FUNCTIONAL IMAGING I Feb-08-2023
10 Hermes Medical Solutions AB II Dec-12-2024
11 Philips North America I Feb-02-2024
12 Philips North America II Jan-05-2024
13 Philips North America Llc II Nov-24-2021
14 Philips North America Llc II Jun-30-2021
15 Shanghai United Imaging Healthcare Co., Ltd. II Apr-07-2023
16 Shanghai United Imaging Healthcare Co., Ltd. II Oct-13-2022
17 Shanghai United Imaging Healthcare Co., Ltd. II Sep-29-2021
18 Shanghai United Imaging Healthcare Co., Ltd. II Nov-12-2020
19 Shanghai United Imaging Healthcare Co., Ltd. II Aug-18-2020
20 Shanghai United Imaging Healthcare Co., Ltd. II Aug-13-2020
21 Shanghai United Imaging Healthcare Co., Ltd. II Apr-15-2020
22 Siemens Medical Solutions USA, Inc. II Jul-28-2023
23 Siemens Medical Solutions USA, Inc. II Feb-13-2023
24 Siemens Medical Solutions USA, Inc. II Apr-07-2022
25 Siemens Medical Solutions USA, Inc. II Sep-02-2020
26 Siemens Medical Solutions USA, Inc. II Aug-27-2020
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