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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 2
ACREW IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
ALLENGERS MEDICAL SYSTEMS LIMITED
  SUBSTANTIALLY EQUIVALENT 2
ALPHATEC SPINE, INC.
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 1
CANON INC.
  SUBSTANTIALLY EQUIVALENT 1
CANON MEDICAL SYSTEMS CORPORATION
  SUBSTANTIALLY EQUIVALENT 4
CANON, INC.
  SUBSTANTIALLY EQUIVALENT 1
CARANX MEDICAL
  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 2
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
MEDICATECH USA INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 2
MEDTRONIC INC.
  SUBSTANTIALLY EQUIVALENT 1
MEDTRONIC NAVIGATION, INC
  SUBSTANTIALLY EQUIVALENT 1
MICRONICA SRL
  SUBSTANTIALLY EQUIVALENT 1
MX IMAGING, INC.
  SUBSTANTIALLY EQUIVALENT 1
NANJING PERLOVE MEDICAL EQUIPMENT CO., LTD.
  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
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 1
SIEMENS MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 3
SIEMENS MEDICAL SOLUTIONS USA, INC
  SUBSTANTIALLY EQUIVALENT 4
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 12

MDR Year MDR Reports MDR Events
2020 1581 1581
2021 1981 1982
2022 2933 2933
2023 7610 7610
2024 7952 7952
2025 7647 7647

Device Problems MDRs with this Device Problem Events in those MDRs
Activation Failure 9090 9090
Radiation Output Failure 8337 8338
Application Program Freezes, Becomes Nonfunctional 3471 3471
Positioning Failure 2408 2408
No Display/Image 1181 1181
Positioning Problem 946 946
Failure to Advance 648 648
Noise, Audible 623 623
Device Sensing Problem 560 560
Poor Quality Image 468 468
Application Program Problem 410 410
Communication or Transmission Problem 386 386
Use of Device Problem 321 321
Unexpected Shutdown 316 316
Mechanical Problem 305 305
Adverse Event Without Identified Device or Use Problem 304 304
Failure to Power Up 301 301
Radiation Output Problem 233 233
Image Display Error/Artifact 217 217
Detachment of Device or Device Component 203 203
Imprecision 192 192
Failure to Run on Battery 168 168
Unintended System Motion 163 163
Output Problem 158 158
Incorrect, Inadequate or Imprecise Result or Readings 156 156
Material Deformation 156 156
Physical Resistance/Sticking 142 142
Display or Visual Feedback Problem 137 137
Unintended Movement 122 122
Power Problem 119 119
Insufficient Information 109 109
Failure to Charge 107 107
Smoking 91 91
No Device Output 85 85
Calibration Problem 76 76
Electrical /Electronic Property Problem 70 70
No Apparent Adverse Event 61 61
Unintended Collision 52 52
Mechanical Jam 46 46
Erratic or Intermittent Display 46 46
Device Damaged Prior to Use 46 46
Failure to Transmit Record 44 44
Computer Software Problem 43 43
Device Operational Issue 41 41
Data Problem 40 40
Difficult or Delayed Activation 38 38
Wireless Communication Problem 35 35
Unexpected/Unintended Radiation Output 35 35
Connection Problem 34 34
Unintended Electrical Shock 32 32

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 28068 28069
No Patient Involvement 755 755
No Known Impact Or Consequence To Patient 486 486
Insufficient Information 331 332
No Consequences Or Impact To Patient 56 56
Unspecified Tissue Injury 39 39
Unintended Radiation Exposure 29 29
Radiation Exposure, Unintended 29 29
Hair Loss 23 23
Bone Fracture(s) 19 19
Laceration(s) 18 18
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 17 17
Fall 17 17
Pain 16 16
Bruise/Contusion 13 13
Cardiac Arrest 12 12
Crushing Injury 10 10
Hemorrhage/Bleeding 8 8
Tissue Damage 7 7
Death 6 6
Injury 5 5
Muscle/Tendon Damage 5 5
Post Operative Wound Infection 4 4
Aneurysm 4 4
Electric Shock 4 4
Radiation Burn 4 4
Myocardial Infarction 4 4
Ruptured Aneurysm 4 4
Perforation 4 4
Head Injury 4 4
Hematoma 4 4
Muscle Weakness 4 4
Skin Tears 3 3
Abrasion 3 3
Thrombosis/Thrombus 3 3
Embolism/Embolus 3 3
Perforation of Vessels 3 3
Nerve Damage 3 3
No Information 3 3
Headache 3 3
Failure of Implant 3 3
Patient Problem/Medical Problem 3 3
Unspecified Infection 3 3
Swelling/ Edema 2 2
Loss of Range of Motion 2 2
Concussion 2 2
Discomfort 2 2
Cardiopulmonary Arrest 2 2
Dyspnea 2 2
Paresis 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, LLC II Aug-22-2025
13 GE Medical Systems, SCS II May-06-2024
14 GE OEC Medical Systems, Inc II Jul-31-2023
15 GE OEC Medical Systems, Inc II Jul-29-2021
16 Medtronic Navigation, Inc.-Boxborough II Jul-09-2025
17 Medtronic Navigation, Inc.-Littleton II Jun-06-2024
18 Medtronic Navigation, Inc.-Littleton II Aug-24-2023
19 NRT X-RAY A/S II May-07-2024
20 NRT X-RAY A/S II May-31-2023
21 NRT X-RAY A/S II Jan-25-2022
22 Orthoscan, Inc. II Dec-02-2024
23 PHILIPS HOME HEALTHCARE SOLUTION II Jan-28-2021
24 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Oct-01-2025
25 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-25-2025
26 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-03-2025
27 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-03-2025
28 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jul-29-2025
29 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jul-18-2025
30 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jun-12-2025
31 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. I Feb-20-2025
32 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-04-2025
33 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-12-2024
34 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Nov-12-2024
35 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-30-2024
36 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-18-2024
37 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-04-2024
38 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-22-2024
39 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-08-2024
40 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-24-2024
41 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-22-2024
42 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
43 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
44 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-16-2024
45 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
46 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-30-2024
47 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Jan-26-2024
48 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Dec-15-2023
49 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Sep-14-2023
50 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-30-2023
51 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Aug-02-2023
52 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Apr-20-2023
53 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II May-03-2022
54 PHILIPS MEDICAL SYSTEMS NEDERLAND B.V. II Feb-17-2022
55 Philips Healthcare II Apr-05-2022
56 Philips Healthcare II Mar-23-2022
57 Philips Healthcare II Nov-24-2021
58 Philips Healthcare II Nov-24-2021
59 Philips Medical Systems Nederland B.V. II Apr-21-2025
60 Philips Medical Systems Nederland B.V. II Sep-07-2023
61 Philips Medical Systems Nederlands II Jun-21-2021
62 Philips North America, LLC II Sep-30-2020
63 Philips North America, LLC II May-08-2020
64 Philips North America, LLC II Apr-29-2020
65 Philips North America, LLC II Mar-13-2020
66 Philips North America, LLC II Feb-10-2020
67 Philips North America II Sep-30-2024
68 Philips North America Llc II Apr-21-2025
69 Philips North America Llc II Apr-28-2023
70 Philips North America Llc II Mar-04-2022
71 Philips North America Llc II Jan-10-2022
72 Philips North America Llc II Jan-10-2022
73 Philips North America Llc II Dec-22-2021
74 Philips North America Llc II Dec-09-2021
75 Philips North America Llc II Sep-14-2021
76 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Oct-22-2024
77 SHIMADZU CORPORATION MEDICAL SYSTEMS DIVISION II Mar-14-2024
78 SIEMENS MEDICAL SOLUTIONS USA, INC II Jan-29-2025
79 Shimadzu Medical Systems II Feb-28-2022
80 Shimadzu Medical Systems II Dec-10-2020
81 Shimadzu Medical Systems II Jul-14-2020
82 Siemens AG/Siemens Healthcare GmbH II Jul-02-2024
83 Siemens Medical Solutions USA, Inc II Sep-05-2025
84 Siemens Medical Solutions USA, Inc II Jun-27-2025
85 Siemens Medical Solutions USA, Inc II Aug-07-2024
86 Siemens Medical Solutions USA, Inc II Apr-18-2024
87 Siemens Medical Solutions USA, Inc II Dec-09-2023
88 Siemens Medical Solutions USA, Inc II Oct-27-2023
89 Siemens Medical Solutions USA, Inc II Aug-08-2023
90 Siemens Medical Solutions USA, Inc II Jul-27-2023
91 Siemens Medical Solutions USA, Inc II May-23-2023
92 Siemens Medical Solutions USA, Inc II May-02-2023
93 Siemens Medical Solutions USA, Inc II Apr-27-2023
94 Siemens Medical Solutions USA, Inc II Mar-30-2023
95 Siemens Medical Solutions USA, Inc II Feb-23-2023
96 Siemens Medical Solutions USA, Inc II Jan-30-2023
97 Siemens Medical Solutions USA, Inc II Jan-20-2023
98 Siemens Medical Solutions USA, Inc II Jan-13-2023
99 Siemens Medical Solutions USA, Inc II Aug-26-2022
100 Siemens Medical Solutions USA, Inc II Jul-07-2022
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