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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
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
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

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 29 31
Unintended Movement 25 25
Therapeutic or Diagnostic Output Failure 14 14
Mechanical Problem 12 12
Computer Operating System Problem 12 12
Electrical /Electronic Property Problem 12 12
Detachment of Device or Device Component 11 11
Use of Device Problem 10 10
Device Operational Issue 10 10
Smoking 10 10
Break 8 8
No Display/Image 8 8
Device Fell 8 8
Device Displays Incorrect Message 7 7
Improper or Incorrect Procedure or Method 7 7
Sparking 6 6
Battery Problem 5 5
Radiation Overexposure 5 5
Positioning Problem 5 5
Material Integrity Problem 5 5
Insufficient Information 5 5
Protective Measures Problem 4 4
No Apparent Adverse Event 4 4
Device Handling Problem 4 4
Loose or Intermittent Connection 4 4
Image Display Error/Artifact 4 4
Unstable 4 4
Degraded 3 3
Output Problem 3 3
Naturally Worn 3 3
Thermal Decomposition of Device 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
Radiation Output Failure 2 2
Adverse Event Without Identified Device or Use Problem 2 2
Inadequate or Insufficient Training 2 2
Unexpected/Unintended Radiation Output 2 2
Material Deformation 2 2
Data Problem 2 2
Fire 2 2
Product Quality Problem 2 2
Electrical Shorting 2 2
Installation-Related Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 115 116
Insufficient Information 50 51
No Known Impact Or Consequence To Patient 14 14
Bone Fracture(s) 7 7
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
Unspecified Infection 1 1
Electric Shock 1 1
Fatigue 1 1
No Information 1 1
Head Injury 1 1
Muscle Weakness 1 1
Chemical Exposure 1 1
Burn(s) 1 1
Nerve Damage 1 1
Hyperextension 1 1
Undesired Nerve Stimulation 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 Dec-12-2024
10 Micro-X Ltd. II Dec-12-2024
11 Micro-X Ltd. II Dec-12-2024
12 Micro-X Ltd. II Nov-27-2024
13 Micro-X Ltd. II Sep-23-2022
14 NeuroLogica Corporation II Aug-22-2024
15 NeuroLogica Corporation II Feb-09-2024
16 NeuroLogica Corporation II Apr-19-2023
17 SEDECAL SA II May-02-2024
18 SEDECAL SA II Feb-14-2024
19 SEDECAL SA II Jun-30-2023
20 SEDECAL SA II Mar-02-2023
21 SEDECAL SA II Nov-04-2022
22 Shimadzu Medical Systems II Dec-04-2020
23 Siemens Medical Solutions USA, Inc II Nov-14-2023
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