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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, mobile
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
ASPENSTATE INC
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH INC.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
ECORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
ENERGY RESOURCES INTERNATIONAL CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
FIRST SOURCE INC.
  SUBSTANTIALLY EQUIVALENT 2
GE MEDICAL SYSTEMS, LLC
  SUBSTANTIALLY EQUIVALENT 1
HDT CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LTD.
  SUBSTANTIALLY EQUIVALENT 1
MINXRAY, INC
  SUBSTANTIALLY EQUIVALENT 1
MINXRAY, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
NANO-X IMAGING LTD.
  SUBSTANTIALLY EQUIVALENT 1
NEUF INC.
  SUBSTANTIALLY EQUIVALENT 2
OXOS MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 1
POSKOM CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX LLC
  SUBSTANTIALLY EQUIVALENT 1
REMEDI CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO. LTD.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
SEDECAL SA
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 4
SHENZHEN BROWINER TECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
SKANRAY TECHNOLOGIES LIMITED
  SUBSTANTIALLY EQUIVALENT 1
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 1
SUZHOU POWERSITE ELECTRIC CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
VATECH CO., LTD
  SUBSTANTIALLY EQUIVALENT 2
VMI TECNOLOGIAS LTDA
  SUBSTANTIALLY EQUIVALENT 1
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2020 48 48
2021 47 49
2022 32 32
2023 77 77
2024 39 39
2025 7 7

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 29 31
Unintended Movement 26 26
Therapeutic or Diagnostic Output Failure 14 14
Detachment of Device or Device Component 12 12
Computer Operating System Problem 12 12
Electrical /Electronic Property Problem 12 12
Mechanical Problem 12 12
Use of Device Problem 10 10
Smoking 10 10
Device Operational Issue 10 10
Device Fell 10 10
Break 8 8
No Display/Image 8 8
Device Displays Incorrect Message 7 7
Improper or Incorrect Procedure or Method 7 7
Device Handling Problem 6 6
Sparking 6 6
Insufficient Information 5 5
Material Integrity Problem 5 5
Positioning Problem 5 5
Radiation Overexposure 5 5
Battery Problem 5 5
Image Display Error/Artifact 4 4
Protective Measures Problem 4 4
No Apparent Adverse Event 4 4
Loose or Intermittent Connection 4 4
Unstable 4 4
Degraded 4 4
Computer Software Problem 3 3
Device Emits Odor 3 3
Labelling, Instructions for Use or Training Problem 3 3
Human-Device Interface Problem 3 3
Thermal Decomposition of Device 3 3
Naturally Worn 3 3
Unintended Collision 3 3
Output Problem 3 3
Radiation Output Failure 2 2
Fire 2 2
Patient Data Problem 2 2
Unexpected/Unintended Radiation Output 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Inadequate or Insufficient Training 2 2
Material Deformation 2 2
Data Problem 2 2
Defective Device 2 2
Product Quality Problem 2 2
Electrical Shorting 2 2
Installation-Related Problem 2 2
Unintended Electrical Shock 2 2
Activation Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 119 120
Insufficient Information 51 52
No Known Impact Or Consequence To Patient 14 14
Bone Fracture(s) 8 8
Radiation Exposure, Unintended 6 6
Unintended Radiation Exposure 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Crushing Injury 4 4
Pain 4 4
Bruise/Contusion 4 4
Patient Problem/Medical Problem 3 3
Abrasion 3 3
No Patient Involvement 3 3
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Superficial (First Degree) Burn 2 2
Hematoma 2 2
Unspecified Tissue Injury 2 2
Abdominal Pain 1 1
Unspecified Infection 1 1
Electric Shock 1 1
Fatigue 1 1
Dizziness 1 1
No Information 1 1
Head Injury 1 1
Inflammation 1 1
Muscle Weakness 1 1
Abdominal Cramps 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Foreign Body Reaction 1 1
Burn(s) 1 1
Nerve Damage 1 1
Twitching 1 1
Hyperextension 1 1
Undesired Nerve Stimulation 1 1
Blurred Vision 1 1
Unspecified Respiratory Problem 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Agfa N.V. II Apr-02-2024
2 Carestream Health, Inc. II Dec-01-2023
3 Carestream Health, Inc. II Nov-09-2023
4 FUJIFILM Healthcare Americas Corporation II Sep-25-2024
5 FUJIFILM Healthcare Americas Corporation II Apr-27-2023
6 First Source Inc II Jul-01-2024
7 GE Healthcare, LLC II Sep-29-2021
8 GE Medical Systems, LLC II Jan-07-2025
9 Micro-X Ltd. II Apr-24-2025
10 Micro-X Ltd. II Apr-16-2025
11 Micro-X Ltd. II Dec-12-2024
12 Micro-X Ltd. II Dec-12-2024
13 Micro-X Ltd. II Dec-12-2024
14 Micro-X Ltd. II Nov-27-2024
15 Micro-X Ltd. II Sep-23-2022
16 NeuroLogica Corporation II Aug-22-2024
17 NeuroLogica Corporation II Feb-09-2024
18 NeuroLogica Corporation II Apr-19-2023
19 SEDECAL SA II May-02-2024
20 SEDECAL SA II Feb-14-2024
21 SEDECAL SA II Jun-30-2023
22 SEDECAL SA II Mar-02-2023
23 SEDECAL SA II Nov-04-2022
24 Shimadzu Medical Systems II Dec-04-2020
25 Siemens Medical Solutions USA, Inc II Nov-14-2023
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