Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search show TPLC since Back to Search Results
Device system, x-ray, mobile
Regulation Description Mobile x-ray system.
Product CodeIZL
Regulation Number 892.1720
Device Class 2


Premarket Reviews
ManufacturerDecision
AGFA N.V.
  SUBSTANTIALLY EQUIVALENT 1
ASPENSTATE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BONTECH CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH
  SUBSTANTIALLY EQUIVALENT 1
CARESTREAM HEALTH, INC.
  SUBSTANTIALLY EQUIVALENT 2
DK MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRGEM CORPORATION
  SUBSTANTIALLY EQUIVALENT 5
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 3
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 2
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 7
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 MEDI CAL SOLUTIONS, INC.
  SUBSTANTIALLY EQUIVALENT 1
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
2019 40 40
2020 48 48
2021 47 50
2022 32 32
2023 77 77
2024 39 39
2025 27 27
2026 5 5

Device Problems MDRs with this Device Problem Events in those MDRs
Unintended System Motion 43 45
Unintended Movement 32 32
Use of Device Problem 22 22
Detachment of Device or Device Component 20 20
Therapeutic or Diagnostic Output Failure 15 15
Smoking 15 15
Mechanical Problem 13 13
Electrical /Electronic Property Problem 13 13
Computer Operating System Problem 12 12
Device Fell 12 12
Improper or Incorrect Procedure or Method 12 12
Device Operational Issue 12 12
Break 11 11
Device Handling Problem 9 9
No Display/Image 9 10
Insufficient Information 9 9
Device Displays Incorrect Message 7 7
Sparking 7 7
Image Display Error/Artifact 6 6
No Apparent Adverse Event 6 6
Loose or Intermittent Connection 5 5
Material Integrity Problem 5 5
Positioning Problem 5 5
Radiation Overexposure 5 5
Battery Problem 5 5
Protective Measures Problem 4 5
Fire 4 4
Degraded 4 4
Unstable 4 4
Adverse Event Without Identified Device or Use Problem 4 4
Human-Device Interface Problem 3 3
Naturally Worn 3 3
Output Problem 3 3
Arcing 3 3
Computer Software Problem 3 3
Unexpected/Unintended Radiation Output 3 3
Device Emits Odor 3 3
Labelling, Instructions for Use or Training Problem 3 3
Thermal Decomposition of Device 3 3
Unintended Collision 3 3
Connection Problem 2 2
Inadequate or Insufficient Training 2 2
Activation Failure 2 2
Installation-Related Problem 2 2
Electrical Shorting 2 2
Product Quality Problem 2 2
Data Problem 2 2
Material Deformation 2 2
Misassembly During Maintenance/Repair 2 2
Circuit Failure 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 133 134
Insufficient Information 53 54
No Known Impact Or Consequence To Patient 27 27
No Consequences Or Impact To Patient 17 17
Bone Fracture(s) 8 8
Unintended Radiation Exposure 7 8
No Patient Involvement 7 7
Radiation Exposure, Unintended 6 6
Bruise/Contusion 5 5
Superficial (First Degree) Burn 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Death 4 4
Crushing Injury 4 4
Abrasion 4 4
Pain 4 4
Patient Problem/Medical Problem 3 3
No Code Available 3 3
Hematoma 3 3
Aspiration/Inhalation 3 3
Laceration(s) 3 3
Unspecified Infection 2 2
Pneumothorax 2 2
Full thickness (Third Degree) Burn 2 2
Partial thickness (Second Degree) Burn 2 2
Unspecified Tissue Injury 2 2
Blurred Vision 1 1
Unspecified Respiratory Problem 1 1
Radiation Burn 1 1
Undesired Nerve Stimulation 1 1
Hyperextension 1 1
Twitching 1 1
Nerve Damage 1 1
Burn(s) 1 1
Foreign Body Reaction 1 1
Cognitive Changes 1 1
Chemical Exposure 1 1
Abdominal Cramps 1 1
Inflammation 1 1
Muscle Weakness 1 1
Head Injury 1 1
Dizziness 1 1
No Information 1 1
Fatigue 1 1
Electric Shock 1 1
Abdominal Pain 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 Fujifilm Medical Systems U.S.A., Inc. II Aug-30-2019
8 Fujifilm Medical Systems U.S.A., Inc. II Mar-21-2019
9 GE Healthcare, LLC II Sep-29-2021
10 GE Medical Systems, LLC II Jan-07-2025
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 NeuroLogica Corporation II May-30-2019
23 SEDECAL SA II Oct-23-2025
24 SEDECAL SA II May-02-2024
25 SEDECAL SA II Feb-14-2024
26 SEDECAL SA II Jun-30-2023
27 SEDECAL SA II Mar-02-2023
28 SEDECAL SA II Nov-04-2022
29 Shimadzu Medical Systems II Dec-04-2020
30 Shimadzu Medical Systems Usa Com II Mar-21-2019
31 Siemens Medical Solutions USA, Inc II Nov-14-2023
-
-