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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device interventional fluoroscopic x-ray system
Regulation Description Image-intensified 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 1
ACREW IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CIRCINUS MEDICAL TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
CONTROLRAD, INC
  SUBSTANTIALLY EQUIVALENT 2
CONTROLRAD, INC.
  SUBSTANTIALLY EQUIVALENT 2
CYDAR LTD.
  SUBSTANTIALLY EQUIVALENT 1
DRTECH CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
ECENTIAL ROBOTICS
  SUBSTANTIALLY EQUIVALENT 2
EPICA INTERNATIONAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
FUJIFILM CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
GE MEDICAL SYSTEMS SCS
  SUBSTANTIALLY EQUIVALENT 2
GEMSS HEALTHCARE CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
GENORAY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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 1
MEDTRONIC NAVIGATION, INC
  SUBSTANTIALLY EQUIVALENT 1
MICRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
MX IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NDR MEDICAL TECHNOLOGY PTE. LTD.
  SUBSTANTIALLY EQUIVALENT 1
NVIEW MEDICAL
  SUBSTANTIALLY EQUIVALENT 2
OMEGA MEDICAL IMAGING, LLC
  SUBSTANTIALLY EQUIVALENT 1
OXOS MEDICAL
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS INDIA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
PHILIPS MEDICAL SYSTEMS NEDERLAND BV
  SUBSTANTIALLY EQUIVALENT 3
PHILIPS MEDICAL SYSTEMS NEDERLANDS B.V.
  SUBSTANTIALLY EQUIVALENT 2
PHILIPS MEDICAL SYSTEMS, NEDERLAND B.V.
  SUBSTANTIALLY EQUIVALENT 1
PORTAVISION MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 2
RADIACTION LTD.
  SUBSTANTIALLY EQUIVALENT 2
SG 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 1
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 12
SIEMENS MEDICAL SYSTEMS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
STEPHANIX
  SUBSTANTIALLY EQUIVALENT 2
SURGIVISIO
  SUBSTANTIALLY EQUIVALENT 1
THERENVA SAS
  SUBSTANTIALLY EQUIVALENT 2
TRACK X TECHNOLOGY, LLC
  SUBSTANTIALLY EQUIVALENT 1
XORAN TECHNOLOGIES LLC
  SUBSTANTIALLY EQUIVALENT 1
ZIEHM IMAGING GMBH
  SUBSTANTIALLY EQUIVALENT 11

MDR Year MDR Reports MDR Events
2020 1581 1581
2021 1981 1981
2022 2933 2933
2023 7611 7611
2024 7957 7957
2025 1744 1744

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 6638 6638
Radiation Output Failure 6448 6448
Application Program Freezes, Becomes Nonfunctional 3265 3265
Positioning Failure 1855 1855
No Display/Image 946 946
Positioning Problem 895 895
Noise, Audible 555 555
Device Sensing Problem 545 545
Poor Quality Image 455 455
Communication or Transmission Problem 373 373
Failure to Advance 351 351
Application Program Problem 317 317
Unexpected Shutdown 309 309
Use of Device Problem 301 301
Failure to Power Up 292 292
Adverse Event Without Identified Device or Use Problem 255 255
Mechanical Problem 232 232
Image Display Error/Artifact 211 211
Radiation Output Problem 205 205
Imprecision 192 192
Failure to Run on Battery 168 168
Detachment of Device or Device Component 162 162
Output Problem 145 145
Material Deformation 143 143
Physical Resistance/Sticking 138 138
Unintended Movement 120 120
Unintended System Motion 115 115
Incorrect, Inadequate or Imprecise Result or Readings 111 111
Failure to Charge 106 106
Power Problem 106 106
Insufficient Information 90 90
Display or Visual Feedback Problem 84 84
No Device Output 83 83
Smoking 79 79
Electrical /Electronic Property Problem 70 70
Calibration Problem 68 68
No Apparent Adverse Event 56 56
Unintended Collision 47 47
Erratic or Intermittent Display 43 43
Failure to Transmit Record 42 42
Device Operational Issue 41 41
Mechanical Jam 40 40
Data Problem 37 37
Device Damaged Prior to Use 36 36
Difficult or Delayed Activation 36 36
Computer Software Problem 34 34
Connection Problem 34 34
Wireless Communication Problem 32 32
Unexpected/Unintended Radiation Output 32 32
Arcing 28 28

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 22200 22200
No Patient Involvement 755 755
No Known Impact Or Consequence To Patient 486 486
Insufficient Information 289 289
No Consequences Or Impact To Patient 56 56
Unspecified Tissue Injury 40 40
Unintended Radiation Exposure 29 29
Radiation Exposure, Unintended 29 29
Hair Loss 23 23
Laceration(s) 16 16
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 15 15
Pain 15 15
Bone Fracture(s) 15 15
Fall 13 13
Bruise/Contusion 12 12
Cardiac Arrest 11 11
Crushing Injury 10 10
Hemorrhage/Bleeding 8 8
Tissue Damage 7 7
Death 6 6
Muscle/Tendon Damage 5 5
Injury 5 5
Ruptured Aneurysm 4 4
Myocardial Infarction 4 4
Electric Shock 4 4
Muscle Weakness 4 4
Headache 3 3
Radiation Burn 3 3
Aneurysm 3 3
Perforation of Vessels 3 3
Post Operative Wound Infection 3 3
Abrasion 3 3
Embolism/Embolus 3 3
Perforation 3 3
Hematoma 3 3
Head Injury 3 3
Unspecified Infection 3 3
Failure of Implant 3 3
No Information 3 3
Patient Problem/Medical Problem 3 3
Swelling/ Edema 2 2
Stroke/CVA 2 2
Radiation Overdose 2 2
Coma 2 2
Paresis 2 2
Skin Tears 2 2
Convulsion/Seizure 2 2
Dyspnea 2 2
Cardiopulmonary Arrest 2 2
Unspecified Heart Problem 2 2

Recalls
Manufacturer Recall Class Date Posted
1 Canon Medical System, USA, INC. II Feb-16-2024
2 Canon Medical System, USA, INC. II Aug-11-2023
3 Canon Medical System, USA, INC. II Sep-02-2022
4 Canon Medical System, USA, INC. II Jun-24-2022
5 Canon Medical System, USA, INC. II Jan-12-2022
6 Canon Medical System, USA, INC. II Mar-17-2021
7 Canon Medical System, USA, INC. II Mar-09-2021
8 Canon Medical System, USA, INC. II Dec-03-2020
9 Canon Medical System, USA, INC. II Aug-25-2020
10 Canon Medical System, USA, INC. II Jun-09-2020
11 GE Healthcare, LLC II Jun-15-2021
12 GE Medical Systems, SCS II May-06-2024
13 GE OEC Medical Systems, Inc II Jul-31-2023
14 GE OEC Medical Systems, Inc II Jul-29-2021
15 Medtronic Navigation, Inc.-Littleton II Jun-06-2024
16 Medtronic Navigation, Inc.-Littleton II Aug-24-2023
17 NRT X-RAY A/S II May-07-2024
18 NRT X-RAY A/S II May-31-2023
19 NRT X-RAY A/S II Jan-25-2022
20 Orthoscan, Inc. II Dec-02-2024
21 PHILIPS HOME HEALTHCARE SOLUTION II Jan-28-2021
22 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. I Feb-20-2025
23 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-04-2025
24 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-12-2024
25 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Nov-12-2024
26 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-30-2024
27 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
28 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-04-2024
29 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-22-2024
30 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-08-2024
31 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-24-2024
32 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-22-2024
33 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
34 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
35 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
36 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
37 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
38 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-26-2024
39 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-15-2023
40 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-14-2023
41 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-30-2023
42 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-02-2023
43 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Apr-20-2023
44 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
45 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
46 Philips Healthcare II Apr-05-2022
47 Philips Healthcare II Mar-23-2022
48 Philips Healthcare II Nov-24-2021
49 Philips Healthcare II Nov-24-2021
50 Philips Medical Systems Nederland B.V. II Sep-07-2023
51 Philips Medical Systems Nederlands II Jun-21-2021
52 Philips North America, LLC II Sep-30-2020
53 Philips North America, LLC II May-08-2020
54 Philips North America, LLC II Apr-29-2020
55 Philips North America, LLC II Mar-13-2020
56 Philips North America, LLC II Feb-10-2020
57 Philips North America II Sep-30-2024
58 Philips North America Llc II Apr-28-2023
59 Philips North America Llc II Mar-04-2022
60 Philips North America Llc II Jan-10-2022
61 Philips North America Llc II Jan-10-2022
62 Philips North America Llc II Dec-22-2021
63 Philips North America Llc II Dec-09-2021
64 Philips North America Llc II Sep-14-2021
65 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Oct-22-2024
66 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Mar-14-2024
67 SIEMENS MEDICAL SOLUTIONS USA, INC II Jan-29-2025
68 Shimadzu Medical Systems II Feb-28-2022
69 Shimadzu Medical Systems II Dec-10-2020
70 Shimadzu Medical Systems II Jul-14-2020
71 Siemens AG/Siemens Healthcare GmbH II Jul-02-2024
72 Siemens Medical Solutions USA, Inc II Aug-07-2024
73 Siemens Medical Solutions USA, Inc II Apr-18-2024
74 Siemens Medical Solutions USA, Inc II Dec-09-2023
75 Siemens Medical Solutions USA, Inc II Oct-27-2023
76 Siemens Medical Solutions USA, Inc II Aug-08-2023
77 Siemens Medical Solutions USA, Inc II Jul-27-2023
78 Siemens Medical Solutions USA, Inc II May-23-2023
79 Siemens Medical Solutions USA, Inc II May-02-2023
80 Siemens Medical Solutions USA, Inc II Apr-27-2023
81 Siemens Medical Solutions USA, Inc II Mar-30-2023
82 Siemens Medical Solutions USA, Inc II Feb-23-2023
83 Siemens Medical Solutions USA, Inc II Jan-30-2023
84 Siemens Medical Solutions USA, Inc II Jan-20-2023
85 Siemens Medical Solutions USA, Inc II Jan-13-2023
86 Siemens Medical Solutions USA, Inc II Aug-26-2022
87 Siemens Medical Solutions USA, Inc II Jul-07-2022
88 Siemens Medical Solutions USA, Inc II Jul-06-2022
89 Siemens Medical Solutions USA, Inc II Jun-07-2022
90 Siemens Medical Solutions USA, Inc II Apr-21-2022
91 Siemens Medical Solutions USA, Inc II Apr-21-2022
92 Siemens Medical Solutions USA, Inc II Jan-21-2022
93 Siemens Medical Solutions USA, Inc II Nov-24-2021
94 Siemens Medical Solutions USA, Inc II Nov-04-2021
95 Siemens Medical Solutions USA, Inc II Sep-02-2021
96 Siemens Medical Solutions USA, Inc II Jul-07-2021
97 Siemens Medical Solutions USA, Inc II Jun-02-2021
98 Siemens Medical Solutions USA, Inc II May-13-2021
99 Siemens Medical Solutions USA, Inc II Apr-26-2021
100 Siemens Medical Solutions USA, Inc II Apr-26-2021
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