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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device accelerator, linear, medical
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 4
AKTINA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 7
C-RAD POSITIONING AB
  SUBSTANTIALLY EQUIVALENT 2
CARBON MEDICAL TECHNOLOGIES
  SUBSTANTIALLY EQUIVALENT 1
CARBON MEDICAL TECHNOLOGIES INC.
  SUBSTANTIALLY EQUIVALENT 1
CARINA MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
CNMC CO., INC.
  SUBSTANTIALLY EQUIVALENT 1
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
ELECKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 4
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
ELEKTA, INC
  SUBSTANTIALLY EQUIVALENT 1
ESSEBI MEDICAL SRL
  SUBSTANTIALLY EQUIVALENT 1
JIANGSU RAYER MEDICAL TECHNOLOGY CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
KALLISIO, INC
  SUBSTANTIALLY EQUIVALENT 1
KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 3
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 3
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 1
MEDPHOTON GMBH
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC DBA CIVCO MEDICAL SOLUTIONS AND CIVCO RADIOTHERAP
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC INC. DBA CIVCO MEDICAL SOLUTIONS
  SUBSTANTIALLY EQUIVALENT 1
MEDTEC, INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO
  SUBSTANTIALLY EQUIVALENT 1
MICROPOS MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 1
NASLUND MEDICAL AB
  SUBSTANTIALLY EQUIVALENT 2
ORFIT INDUSTRIES NV
  SUBSTANTIALLY EQUIVALENT 2
OUR UNITED CORPORATION
  SUBSTANTIALLY EQUIVALENT 2
PANACEA MEDICAL TECHNOLOGIES PVT LTD
  SUBSTANTIALLY EQUIVALENT 1
PANACEA MEDICAL TECHNOLOGIES PVT.LTD
  SUBSTANTIALLY EQUIVALENT 1
PAPRICALAB
  SUBSTANTIALLY EQUIVALENT 1
POLL MEDICAL LLC
  SUBSTANTIALLY EQUIVALENT 1
PROWESS INC.
  SUBSTANTIALLY EQUIVALENT 1
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN
  SUBSTANTIALLY EQUIVALENT 2
PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN DR. PYCHLA
  SUBSTANTIALLY EQUIVALENT 1
QFIX
  SUBSTANTIALLY EQUIVALENT 3
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADIALOGICA LLC
  SUBSTANTIALLY EQUIVALENT 1
RADIATION PRODUCTS LLC
  SUBSTANTIALLY EQUIVALENT 1
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
RTSAFE, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 2
SIEMENS MEDICAL SOLUTIONS USA, INC.
  SUBSTANTIALLY EQUIVALENT 1
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 2
VARIAN MEDICAL SYSTEMS INC
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 7
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 10
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 6
WISDOM TECHNOLOGIES., INC.
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS
  SUBSTANTIALLY EQUIVALENT 1
ZAP SURGICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 1

MDR Year MDR Reports MDR Events
2018 85 85
2019 91 91
2020 74 74
2021 68 68
2022 67 67
2023 128 128
2024 50 50

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 293 293
Use of Device Problem 35 35
Adverse Event Without Identified Device or Use Problem 23 23
Detachment of Device or Device Component 20 20
Unintended System Motion 19 19
Fluid/Blood Leak 15 15
No Apparent Adverse Event 11 11
Unintended Movement 10 10
Break 9 9
Mechanical Problem 9 9
Unstable 8 8
Data Problem 8 8
Improper or Incorrect Procedure or Method 8 8
Device Handling Problem 8 8
Communication or Transmission Problem 8 8
Unintended Collision 7 7
Application Program Problem: Dose Calculation Error 7 7
Application Program Problem 7 7
Use of Incorrect Control/Treatment Settings 6 6
Material Deformation 6 6
Off-Label Use 6 6
Insufficient Information 6 6
Compatibility Problem 5 5
Installation-Related Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Radiation Overexposure 4 4
Device Operates Differently Than Expected 4 4
Device Fell 4 4
Output Problem 4 4
Electrical /Electronic Property Problem 4 4
Defective Component 3 3
Protective Measures Problem 3 3
Material Integrity Problem 3 3
Human-Device Interface Problem 3 3
Labelling, Instructions for Use or Training Problem 3 3
Loose or Intermittent Connection 3 3
Intermittent Communication Failure 3 3
Therapy Delivered to Incorrect Body Area 3 3
Inadequate User Interface 3 3
Image Orientation Incorrect 2 2
Appropriate Term/Code Not Available 2 2
Inadequate or Insufficient Training 2 2
Application Network Problem 2 2
Connection Problem 2 2
Low impedance 2 2
Component Misassembled 2 2
Material Too Soft/Flexible 2 2
Display or Visual Feedback Problem 2 2
Retraction Problem 2 2
Product Quality Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 245 245
Insufficient Information 202 202
No Known Impact Or Consequence To Patient 89 89
No Information 63 63
No Consequences Or Impact To Patient 58 58
No Patient Involvement 37 37
Radiation Overdose 15 15
Unintended Radiation Exposure 13 13
Bone Fracture(s) 7 7
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 6 6
Radiation Burn 4 4
Radiation Underdose 3 3
Pain 3 3
Abrasion 3 3
Inflammation 3 3
Headache 2 2
Limb Fracture 2 2
Laceration(s) 2 2
Injury 2 2
Burn(s) 2 2
Incontinence 2 2
Local Reaction 2 2
No Code Available 2 2
Neuropathy 2 2
Patient Problem/Medical Problem 2 2
High Blood Pressure/ Hypertension 1 1
Ambulation Difficulties 1 1
Fistula 1 1
Bruise/Contusion 1 1
Constipation 1 1
Cancer 1 1
Irritability 1 1
Urinary Frequency 1 1
Unspecified Infection 1 1
Hot Flashes/Flushes 1 1
Hemorrhage/Bleeding 1 1
Ulcer 1 1
Blurred Vision 1 1
Dysphasia 1 1
Swelling/ Edema 1 1
Non-union Bone Fracture 1 1
Death 1 1
Reaction 1 1
Radiodermatitis 1 1
Tingling 1 1
Complaint, Ill-Defined 1 1
Joint Dislocation 1 1
Fall 1 1
Sweating 1 1
Fatigue 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Aug-31-2023
2 Accuray Incorporated II Mar-17-2021
3 Accuray Incorporated II Jan-07-2021
4 Accuray Incorporated II Jun-01-2019
5 Accuray Incorporated II Nov-08-2018
6 Accuray Incorporated II Sep-20-2018
7 Brainlab AG II Mar-16-2023
8 Brainlab AG II Mar-08-2022
9 Brainlab AG II Jun-10-2021
10 Brainlab AG II Mar-08-2021
11 Brainlab AG II Mar-14-2018
12 C-RAD POSITIONING AB II Jul-14-2021
13 Carbon Medical Technologies, Inc. III Sep-17-2024
14 ELEKTA SOLUTIONS AB II Oct-14-2021
15 Elekta Limited II Jun-08-2020
16 Elekta Limited II May-08-2019
17 Elekta Limited II Apr-08-2019
18 Elekta Limited II Jan-09-2019
19 Elekta Limited II Feb-26-2018
20 Elekta, Inc. II Dec-01-2023
21 Elekta, Inc. II Jun-02-2023
22 Elekta, Inc. II May-30-2023
23 Elekta, Inc. II Oct-14-2021
24 Elekta, Inc. II Sep-29-2021
25 Elekta, Inc. II Jun-02-2021
26 Elekta, Inc. II Jun-30-2020
27 Elekta, Inc. II Jun-05-2020
28 Elekta, Inc. II Aug-09-2019
29 Elekta, Inc. II Jul-16-2019
30 Elekta, Inc. II Feb-08-2019
31 Elekta, Inc. II Dec-27-2018
32 Elekta, Inc. II Aug-23-2018
33 Elekta, Inc. II Aug-17-2018
34 Hitachi Ltd., Medical System Operations Group II May-01-2018
35 Klarity Medical Products LLC II Aug-24-2020
36 Landauer II Dec-22-2023
37 Landauer II Sep-12-2023
38 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
39 Med Tec Inc II Jun-02-2020
40 Med Tec Inc II Jun-18-2019
41 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
42 PTW NORTH AMERICA CORPORATION II Jan-11-2022
43 PTW-FREIBURG II Feb-22-2024
44 PTW-FREIBURG II Sep-11-2023
45 Reflexion Medical, Inc. II Jan-10-2022
46 Siemens Medical Solutions USA, Inc II Dec-09-2022
47 Siemens Medical Solutions USA, Inc II Dec-29-2021
48 Siemens Medical Solutions USA, Inc II Apr-07-2020
49 Siemens Medical Solutions USA, Inc II Feb-21-2020
50 Siemens Medical Solutions USA, Inc II Aug-06-2019
51 Siemens Medical Solutions USA, Inc II Apr-19-2019
52 Siemens Medical Solutions USA, Inc II Apr-17-2018
53 Varian Medical Systems II Oct-01-2018
54 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
55 Varian Medical Systems, Inc. II May-05-2020
56 Viewray, Inc. II Nov-20-2020
57 Viewray, Inc. II Apr-27-2020
58 Viewray, Inc. II Dec-12-2019
59 Viewray, Inc. II May-02-2019
60 Vision RT Ltd II Oct-03-2018
61 Zap Surgical Systems II Sep-14-2022
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