• 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 interventional fluoroscopic x-ray system
Definition Interventional fluoroscopy
Product CodeOWB
Regulation Number 892.1650
Device Class 2


Premarket Reviews
ManufacturerDecision
A.T.S. APPLICAZIONE TECNOLOGIE SPECIALI S.R.L.
  SUBSTANTIALLY EQUIVALENT 2
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 9
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 2
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 2
CONTROLRAD, INC.
  SUBSTANTIALLY EQUIVALENT 3
CYDAR LTD.
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 2
ECOTRON CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE HEALTHCARE
  SUBSTANTIALLY EQUIVALENT 1
GE HUALUN MEDICAL SYSTEMS CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GE OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
GEMSS MEDICAL SYSTEMS CO., LTD
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
GENORAY CO.,LTD
  SUBSTANTIALLY EQUIVALENT 1
GLOBUS MEDICAL INC.
  SUBSTANTIALLY EQUIVALENT 1
IMAGEXRAY, LLC
  SUBSTANTIALLY EQUIVALENT 1
LIVERMORETECH INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 2
MICRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
MX IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NRT X-RAY A/S
  SUBSTANTIALLY EQUIVALENT 1
NUVASIVE, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
NVIEW MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
NVIEW MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
OEC MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL STYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS DMC GMBH
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 8
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PORTAVISION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 3
RADIACTION LTD.
  SUBSTANTIALLY EQUIVALENT 2
SG HEALTHCARE CO LTD
  SUBSTANTIALLY EQUIVALENT 1
SHANGHAI UNITED IMAGING HEALTHCARE CO.,LTD.
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION MEDICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SOLUTION USA, INC.
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 11
SIEMENS MEDICAL SOLUTIONS, INC
  SUBSTANTIALLY EQUIVALENT 1
SIEMENS MEDICAL SYSTEMS USA, INC.
  SUBSTANTIALLY EQUIVALENT 2
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 2
SURGIVISIO
  SUBSTANTIALLY EQUIVALENT 1
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 3
TOSHIBA MEDICAL SYSTEMS COROPORATION
  SUBSTANTIALLY EQUIVALENT 1
TOSHIBA MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 3
TRACK X TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
TRACKX TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
VOLCANO CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 3

MDR Year MDR Reports MDR Events
2017 1604 1604
2018 1449 1449
2019 1558 1558
2020 1581 1581
2021 1981 1981
2022 1715 1715

Device Problems MDRs with this Device Problem Events in those MDRs
Application Program Freezes, Becomes Nonfunctional 2495 2495
Device Operates Differently Than Expected 972 972
Positioning Problem 796 796
Radiation Output Failure 701 701
Communication or Transmission Problem 662 662
Use of Device Problem 479 479
Noise, Audible 426 426
Electrical /Electronic Property Problem 424 424
Device Inoperable 418 418
Poor Quality Image 346 346
Device Sensing Problem 328 328
Failure to Power Up 321 321
Device Displays Incorrect Message 319 319
Failure to Run on Battery 252 252
Device Stops Intermittently 241 241
Insufficient Information 190 190
Adverse Event Without Identified Device or Use Problem 184 184
Imprecision 183 183
Mechanical Problem 180 180
Material Deformation 175 175
Difficult to Open or Close 163 163
Calibration Problem 152 152
Failure to Charge 147 147
Image Display Error/Artifact 135 135
Unexpected Shutdown 133 133
Physical Resistance/Sticking 122 122
No Display/Image 119 119
Output Problem 109 109
Computer Software Problem 107 107
Power Problem 103 103
Unintended Movement 100 100
Application Interface Becomes Non-Functional Or Program Exits Abnormally 82 82
Wireless Communication Problem 79 79
Activation Failure 66 66
Display or Visual Feedback Problem 58 58
No Apparent Adverse Event 53 53
Radiation Output Problem 45 45
Device Operational Issue 44 44
Detachment of Device or Device Component 42 42
No Device Output 42 42
Smoking 42 42
Failure to Shut Off 39 39
Positioning Failure 38 38
Break 37 37
Device Damaged Prior to Use 35 35
Loss of Data 32 32
Data Problem 26 26
Loose or Intermittent Connection 25 25
Overheating of Device 23 23
Unintended Collision 22 22
Connection Problem 21 21
Arcing 21 21
Application Program Problem 20 20
Loss of Power 20 20
Computer Operating System Problem 19 19
Radiation Overexposure 18 18
Improper or Incorrect Procedure or Method 16 16
Therapeutic or Diagnostic Output Failure 16 16
Failure to Obtain Sample 14 14
Unintended System Motion 14 14
Patient Data Problem 13 13
Device Fell 13 13
Unintended Electrical Shock 13 13
Defective Component 12 12
Mechanical Jam 12 12
Bent 11 11
Erratic or Intermittent Display 10 10
Installation-Related Problem 10 10
Temperature Problem 9 9
Defective Device 9 9
Unexpected/Unintended Radiation Output 9 9
Device Handling Problem 9 9
Component Missing 8 8
No Flow 8 8
Material Integrity Problem 8 8
Device Emits Odor 8 8
Device Slipped 8 8
Human-Device Interface Problem 7 7
Device Dislodged or Dislocated 7 7
Material Twisted/Bent 6 6
Operating System Becomes Nonfunctional 6 6
Optical Problem 6 6
Protective Measures Problem 5 5
Failure to Fire 5 5
Device Remains Activated 5 5
Self-Activation or Keying 5 5
Leak/Splash 5 5
Fire 5 5
Premature Discharge of Battery 5 5
Appropriate Term/Code Not Available 5 5
Missing Value Reason 5 5
Intermittent Communication Failure 5 5
Intermittent Loss of Power 4 4
Thermal Decomposition of Device 4 4
Detachment Of Device Component 4 4
Entrapment of Device 4 4
Malposition of Device 4 4
Unstable 4 4
Problem with Software Installation 4 4
Failure to Align 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 3929 3929
No Patient Involvement 3260 3260
No Known Impact Or Consequence To Patient 1987 1987
No Consequences Or Impact To Patient 514 514
Radiation Exposure, Unintended 51 51
Injury 43 43
Death 40 40
Insufficient Information 38 38
Unintended Radiation Exposure 24 24
Hair Loss 18 18
Bone Fracture(s) 16 16
Unspecified Tissue Injury 16 16
Patient Problem/Medical Problem 16 16
Cardiac Arrest 15 15
Tissue Damage 14 14
No Code Available 14 14
Radiation Overdose 13 13
Fall 13 13
Laceration(s) 13 13
Bruise/Contusion 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 11 11
No Information 8 8
Electric Shock 8 8
Radiation Burn 7 7
Burn(s) 6 6
Crushing Injury 6 6
Head Injury 6 6
Pain 6 6
Iatrogenic Source 6 6
Abrasion 5 5
Hemorrhage/Bleeding 4 4
Myocardial Infarction 4 4
Sudden Cardiac Death 3 3
Contusion 3 3
Overdose 3 3
Embolism/Embolus 3 3
Paresthesia 2 2
Muscle/Tendon Damage 2 2
Superficial (First Degree) Burn 2 2
Underdose 2 2
Missing Value Reason 2 2
Vascular Dissection 2 2
Cardiopulmonary Arrest 2 2
Headache 2 2
Hematoma 2 2
Muscle Weakness 2 2
Erythema 2 2
Failure of Implant 2 2
Unspecified Infection 2 2
Skin Inflammation 2 2
Suture Abrasion 2 2
Radiodermatitis 2 2
Concussion 2 2
Seizures 2 2
Skin Irritation 1 1
Skull Fracture 1 1
Spinal Column Injury 1 1
Sprain 1 1
Swelling 1 1
Thrombosis 1 1
Paralysis 1 1
Paresis 1 1
Perforation 1 1
Pneumothorax 1 1
Staphylococcus Aureus 1 1
Dizziness 1 1
Dysphasia 1 1
Nerve Damage 1 1
Neuropathy 1 1
Perforation of Vessels 1 1
Blurred Vision 1 1
Vomiting 1 1
Twitching 1 1
Therapeutic Response, Decreased 1 1
Physical Entrapment 1 1
Anxiety 1 1
Complaint, Ill-Defined 1 1
Fracture, Arm 1 1
Dyskinesia 1 1
Numbness 1 1
Coma 1 1
Irritability 1 1
Obstruction/Occlusion 1 1
Infection, Indirect 1 1
Cardiac Perforation 1 1
Shaking/Tremors 1 1
Burn, Thermal 1 1
Memory Loss/Impairment 1 1
Hearing Impairment 1 1
Hemorrhage, Cerebral 1 1
Intracranial Hemorrhage 1 1
High Blood Pressure/ Hypertension 1 1
Infarction, Cerebral 1 1
Chest Pain 1 1
Congenital Defect/Deformity 1 1
Apnea 1 1
Bacterial Infection 1 1
Perinatal Brain Injury 1 1
Dyspnea 1 1
Shock from Patient Lead(s) 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Barco N.V. II Nov-30-2018
2 Canon Medical System, USA, INC. II Sep-02-2022
3 Canon Medical System, USA, INC. II Jun-24-2022
4 Canon Medical System, USA, INC. II Jan-12-2022
5 Canon Medical System, USA, INC. II Mar-17-2021
6 Canon Medical System, USA, INC. II Mar-09-2021
7 Canon Medical System, USA, INC. II Dec-03-2020
8 Canon Medical System, USA, INC. II Aug-25-2020
9 Canon Medical System, USA, INC. II Jun-09-2020
10 GE Healthcare, LLC II Jun-15-2021
11 GE Medical Systems, SCS II Oct-05-2018
12 GE OEC Medical Systems, Inc II Jul-29-2021
13 GE OEC Medical Systems, Inc II Jan-20-2017
14 GE OEC Medical Systems, Inc II Jan-09-2017
15 Medtronic Navigation, Inc.-Littleton II Dec-31-2019
16 Medtronic Navigation, Inc.-Littleton II Nov-07-2018
17 Medtronic Navigation, Inc.-Littleton II Mar-08-2018
18 NRT X-RAY A/S II Jan-25-2022
19 PHILIPS HOME HEALTHCARE SOLUTION II Jan-28-2021
20 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
21 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
22 Philips Electronics North America Corporation II Sep-21-2018
23 Philips Electronics North America Corporation II May-01-2018
24 Philips Electronics North America Corporation II Feb-24-2018
25 Philips Electronics North America Corporation II Feb-24-2018
26 Philips Electronics North America Corporation II Dec-18-2017
27 Philips Electronics North America Corporation II Apr-14-2017
28 Philips Electronics North America Corporation II Jan-20-2017
29 Philips Healthcare II Apr-05-2022
30 Philips Healthcare II Mar-23-2022
31 Philips Healthcare II Nov-24-2021
32 Philips Healthcare II Nov-24-2021
33 Philips Healthcare II Jul-25-2018
34 Philips Medical Systems Nederlands II Jun-21-2021
35 Philips Medical Systems Nederlands II Jul-30-2019
36 Philips Medical Systems Nederlands II Jun-27-2018
37 Philips North America, LLC II Sep-30-2020
38 Philips North America, LLC II May-08-2020
39 Philips North America, LLC II Apr-29-2020
40 Philips North America, LLC II Mar-13-2020
41 Philips North America, LLC II Feb-10-2020
42 Philips North America, LLC II Aug-06-2019
43 Philips North America, LLC II Mar-23-2019
44 Philips North America Llc II Mar-04-2022
45 Philips North America Llc II Jan-10-2022
46 Philips North America Llc II Jan-10-2022
47 Philips North America Llc II Dec-22-2021
48 Philips North America Llc II Dec-09-2021
49 Philips North America Llc II Sep-14-2021
50 Shimadzu Medical Systems II Feb-28-2022
51 Shimadzu Medical Systems II Dec-10-2020
52 Shimadzu Medical Systems II Jul-14-2020
53 Shimadzu Medical Systems Usa Com II Feb-21-2019
54 Shimadzu Medical Systems Usa Com II Oct-19-2018
55 Siemens Medical Solutions USA, INC II Feb-14-2018
56 Siemens Medical Solutions USA, Inc II Aug-26-2022
57 Siemens Medical Solutions USA, Inc II Jul-07-2022
58 Siemens Medical Solutions USA, Inc II Jul-06-2022
59 Siemens Medical Solutions USA, Inc II Jun-07-2022
60 Siemens Medical Solutions USA, Inc II Apr-21-2022
61 Siemens Medical Solutions USA, Inc II Apr-21-2022
62 Siemens Medical Solutions USA, Inc II Jan-21-2022
63 Siemens Medical Solutions USA, Inc II Nov-24-2021
64 Siemens Medical Solutions USA, Inc II Nov-04-2021
65 Siemens Medical Solutions USA, Inc II Sep-02-2021
66 Siemens Medical Solutions USA, Inc II Jul-07-2021
67 Siemens Medical Solutions USA, Inc II Jun-02-2021
68 Siemens Medical Solutions USA, Inc II May-13-2021
69 Siemens Medical Solutions USA, Inc II Apr-26-2021
70 Siemens Medical Solutions USA, Inc II Apr-26-2021
71 Siemens Medical Solutions USA, Inc II Mar-22-2021
72 Siemens Medical Solutions USA, Inc II Feb-23-2021
73 Siemens Medical Solutions USA, Inc II Jan-11-2021
74 Siemens Medical Solutions USA, Inc II Nov-18-2020
75 Siemens Medical Solutions USA, Inc II Nov-04-2020
76 Siemens Medical Solutions USA, Inc II Oct-27-2020
77 Siemens Medical Solutions USA, Inc II Oct-15-2020
78 Siemens Medical Solutions USA, Inc II Aug-26-2020
79 Siemens Medical Solutions USA, Inc II Aug-22-2020
80 Siemens Medical Solutions USA, Inc II Jun-09-2020
81 Siemens Medical Solutions USA, Inc II Jun-03-2020
82 Siemens Medical Solutions USA, Inc II May-22-2020
83 Siemens Medical Solutions USA, Inc II May-04-2020
84 Siemens Medical Solutions USA, Inc II May-04-2020
85 Siemens Medical Solutions USA, Inc II Mar-13-2020
86 Siemens Medical Solutions USA, Inc II Feb-20-2020
87 Siemens Medical Solutions USA, Inc II Feb-20-2020
88 Siemens Medical Solutions USA, Inc II Feb-20-2020
89 Siemens Medical Solutions USA, Inc II Jan-13-2020
90 Siemens Medical Solutions USA, Inc II Jan-07-2020
91 Siemens Medical Solutions USA, Inc II Dec-17-2019
92 Siemens Medical Solutions USA, Inc II Aug-24-2019
93 Siemens Medical Solutions USA, Inc II Jul-22-2019
94 Siemens Medical Solutions USA, Inc II Jul-09-2019
95 Siemens Medical Solutions USA, Inc II Jun-28-2019
96 Siemens Medical Solutions USA, Inc II May-08-2019
97 Siemens Medical Solutions USA, Inc II May-07-2019
98 Siemens Medical Solutions USA, Inc II Mar-07-2019
99 Siemens Medical Solutions USA, Inc II Nov-14-2018
100 Siemens Medical Solutions USA, Inc II Sep-18-2018
-
-