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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
BONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 1
DK MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
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
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRO-X , LTD.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LIMITED
  SUBSTANTIALLY EQUIVALENT 1
MINXRAY, INC.
  SUBSTANTIALLY EQUIVALENT 2
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
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  SUBSTANTIALLY EQUIVALENT 1
RADMEDIX, LLC
  SUBSTANTIALLY EQUIVALENT 1
REMEDI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
REMEDI, INC.
  SUBSTANTIALLY EQUIVALENT 1
SAMSUNG ELECTRONICS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 3
SEDECAL., SA.
  SUBSTANTIALLY EQUIVALENT 4
SHANGHAI UNITED IMAGING HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
SOLUTIONS FOR TOMORROW AB
  SUBSTANTIALLY EQUIVALENT 2
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 50
2022 32 32
2023 77 77
2024 39 39
2025 26 26

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 32 34
Unintended Movement 26 26
Detachment of Device or Device Component 14 14
Therapeutic or Diagnostic Output Failure 14 14
Mechanical Problem 12 12
Computer Operating System Problem 12 12
Use of Device Problem 12 12
Device Operational Issue 12 12
Electrical /Electronic Property Problem 12 12
Device Fell 11 11
Smoking 10 10
Break 9 9
No Display/Image 8 9
Improper or Incorrect Procedure or Method 8 8
Sparking 7 7
Device Handling Problem 7 7
Device Displays Incorrect Message 7 7
No Apparent Adverse Event 6 6
Insufficient Information 6 6
Battery Problem 5 5
Radiation Overexposure 5 5
Positioning Problem 5 5
Material Integrity Problem 5 5
Protective Measures Problem 4 5
Degraded 4 4
Loose or Intermittent Connection 4 4
Image Display Error/Artifact 4 4
Unstable 4 4
Output Problem 3 3
Thermal Decomposition of Device 3 3
Naturally Worn 3 3
Human-Device Interface Problem 3 3
Unintended Collision 3 3
Labelling, Instructions for Use or Training Problem 3 3
Device Emits Odor 3 3
Computer Software Problem 3 3
Defective Device 2 2
Unintended Electrical Shock 2 2
Electrical Power Problem 2 2
Patient Data Problem 2 2
Arcing 2 2
Radiation Output Failure 2 2
Unexpected/Unintended Radiation Output 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Connection Problem 2 2
Inadequate or Insufficient Training 2 2
Material Deformation 2 2
Data Problem 2 2
Fire 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 131 132
Insufficient Information 53 54
No Known Impact Or Consequence To Patient 14 14
Bone Fracture(s) 8 8
Radiation Exposure, Unintended 6 6
Unintended Radiation Exposure 6 7
Superficial (First Degree) Burn 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Crushing Injury 4 4
Abrasion 4 4
Pain 4 4
Bruise/Contusion 4 4
Patient Problem/Medical Problem 3 3
No Patient Involvement 3 3
Laceration(s) 3 3
No Consequences Or Impact To Patient 3 3
Hematoma 2 2
Unspecified Tissue Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Unspecified Infection 1 1
Abdominal Pain 1 1
Electric Shock 1 1
Fatigue 1 1
No Information 1 1
Dizziness 1 1
Head Injury 1 1
Muscle Weakness 1 1
Inflammation 1 1
Abdominal Cramps 1 1
Chemical Exposure 1 1
Cognitive Changes 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
Unspecified Respiratory Problem 1 1
Blurred Vision 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 Nov-07-2025
17 NeuroLogica Corporation II Aug-22-2024
18 NeuroLogica Corporation II Feb-09-2024
19 NeuroLogica Corporation II Apr-19-2023
20 SEDECAL SA II Oct-23-2025
21 SEDECAL SA II May-02-2024
22 SEDECAL SA II Feb-14-2024
23 SEDECAL SA II Jun-30-2023
24 SEDECAL SA II Mar-02-2023
25 SEDECAL SA II Nov-04-2022
26 Shimadzu Medical Systems II Dec-04-2020
27 Siemens Medical Solutions USA, Inc II Nov-14-2023
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