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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 2
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
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
H&ABYZ CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
HDT CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH, INC.
  SUBSTANTIALLY EQUIVALENT 1
MICRO-X LIMITED
  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 3
PROGNOSYS MEDICAL SYSTEMS PRIVATE LIMITED
  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.
  SUBSTANTIALLY EQUIVALENT 1
SHANTOU INSTITUTE OF ULTRASONIC INSTRUMENTS CO., LTD. (SIUI)
  SUBSTANTIALLY EQUIVALENT 1
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
VSI CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
YIAN MEDICAL TECHNOLOGY (HAINING) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2021 47 50
2022 32 32
2023 77 77
2024 39 39
2025 27 27
2026 19 19

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 26 28
Unintended Movement 19 19
Detachment of Device or Device Component 12 12
Computer Operating System Problem 12 12
Device Fell 11 11
Mechanical Problem 10 10
Device Operational Issue 9 9
Smoking 9 9
Use of Device Problem 7 7
Electrical /Electronic Property Problem 7 7
No Apparent Adverse Event 6 6
Break 6 6
Device Handling Problem 6 6
Insufficient Device Problem Information 6 6
Sparking 5 5
Radiation Overexposure 5 5
Unstable 4 4
Loose or Intermittent Connection 4 4
Sharp Edges 3 3
Naturally Worn 3 3
Battery Problem 3 3
Positioning Problem 3 3
Improper or Incorrect Procedure or Method 3 3
Unexpected/Unintended Radiation Output 3 3
Material Integrity Problem 2 2
Unintended Electrical Shock 2 2
Key or Button Unresponsive/not Working 2 2
Electrical Power Problem 2 2
Image Display Error/Artifact 2 2
Component Missing 2 2
Arcing 2 2
Human-Device Interface Problem 2 2
Inadequate or Insufficient Training 2 2
Mechanical Jam 2 2
Material Deformation 2 2
Unintended Collision 2 2
Labelling, Instructions for Use or Training Problem 2 2
Installation-Related Problem 2 2
Circuit Failure 2 2
Appropriate Device Problem Term/Code Not Available 2 2
Computer Software Problem 2 2
Display or Visual Feedback Problem 1 1
Overheating of Device 1 1
Loss of Data 1 1
Melted 1 1
Grounding Malfunction 1 1
Device Dislodged or Dislocated 1 1
Electrostatic Discharge 1 1
Failure to Advance 1 1
Activation Failure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 136 137
Insufficient Information 52 53
Unintended Radiation Exposure 6 7
Superficial (First Degree) Burn 4 4
Bone Fracture(s) 4 4
Abrasion 4 4
Crushing Injury 4 4
Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available 4 4
Aspiration/Inhalation 3 3
Laceration(s) 3 3
Pain 3 3
Unspecified Tissue Injury 2 2
Partial thickness (Second Degree) Burn 2 2
Full thickness (Third Degree) Burn 2 2
Bruise/Contusion 2 2
Abdominal Pain 1 1
Muscle Weakness/Atrophy 1 1
Electric Shock 1 1
Fatigue 1 1
Radiation Exposure, Unintended 1 1
Dizziness 1 1
Head Injury 1 1
Hematoma 1 1
Inflammation 1 1
Abdominal Cramps 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Cardiac Arrest 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

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 Jul-13-2026
9 GE Medical Systems, LLC II Jan-07-2025
10 Micro-X Ltd. II Apr-22-2026
11 Micro-X Ltd. II Apr-24-2025
12 Micro-X Ltd. II Apr-16-2025
13 Micro-X Ltd. II Dec-12-2024
14 Micro-X Ltd. II Dec-12-2024
15 Micro-X Ltd. II Dec-12-2024
16 Micro-X Ltd. II Nov-27-2024
17 Micro-X Ltd. II Sep-23-2022
18 NeuroLogica Corporation II Nov-07-2025
19 NeuroLogica Corporation II Aug-22-2024
20 NeuroLogica Corporation II Feb-09-2024
21 NeuroLogica Corporation II Apr-19-2023
22 SEDECAL SA II Oct-23-2025
23 SEDECAL SA II May-02-2024
24 SEDECAL SA II Feb-14-2024
25 SEDECAL SA II Jun-30-2023
26 SEDECAL SA II Mar-02-2023
27 SEDECAL SA II Nov-04-2022
28 Siemens Medical Solutions USA, Inc II Nov-14-2023
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