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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 3
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
DOSEOPTICS LLC
  SUBSTANTIALLY EQUIVALENT 2
DOSISOFT
  SUBSTANTIALLY EQUIVALENT 1
DOSISOFT SA
  SUBSTANTIALLY EQUIVALENT 1
ELEKTA LIMITED
  SUBSTANTIALLY EQUIVALENT 3
ELEKTA SOLUTIONS AB
  SUBSTANTIALLY EQUIVALENT 4
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 2
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
  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 2
RADFORMATION, INC.
  SUBSTANTIALLY EQUIVALENT 2
RADTEC MEDICAL DEVICES, INC.
  SUBSTANTIALLY EQUIVALENT 1
REFLEXION MEDICAL, INC.
  SUBSTANTIALLY EQUIVALENT 1
SCANDIDOS AB
  SUBSTANTIALLY EQUIVALENT 2
SIT SORDINA IORT TECHNOLOGIES SPA
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 7
VIEWRAY, INCORPORATED
  SUBSTANTIALLY EQUIVALENT 2
VISCUS BIOLOGICS, LLC
  SUBSTANTIALLY EQUIVALENT 1
VISION RT LTD
  SUBSTANTIALLY EQUIVALENT 5
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
2019 91 91
2020 74 74
2021 68 68
2022 67 67
2023 128 128
2024 71 71

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 259 259
Use of Device Problem 30 30
Detachment of Device or Device Component 21 21
Adverse Event Without Identified Device or Use Problem 21 21
Unintended System Motion 19 19
Fluid/Blood Leak 11 11
Unintended Movement 10 10
Unstable 9 9
Break 9 9
Device Handling Problem 8 8
Communication or Transmission Problem 8 8
Data Problem 7 7
Application Program Problem: Dose Calculation Error 7 7
Application Program Problem 7 7
Unintended Collision 6 6
No Apparent Adverse Event 6 6
Mechanical Problem 6 6
Off-Label Use 6 6
Material Deformation 6 6
Improper or Incorrect Procedure or Method 5 5
Electrical /Electronic Property Problem 4 4
Installation-Related Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Therapeutic or Diagnostic Output Failure 4 4
Device Fell 4 4
Insufficient Information 4 4
Output Problem 4 4
Protective Measures Problem 3 3
Defective Component 3 3
Material Integrity Problem 3 3
Radiation Overexposure 3 3
Inadequate User Interface 3 3
Therapy Delivered to Incorrect Body Area 3 3
Intermittent Communication Failure 3 3
Human-Device Interface Problem 3 3
Use of Incorrect Control/Treatment Settings 3 3
Low impedance 2 2
Compatibility Problem 2 2
Inadequate or Insufficient Training 2 2
Application Network Problem 2 2
Retraction Problem 2 2
Product Quality Problem 2 2
Connection Problem 2 2
Material Too Soft/Flexible 2 2
Calibration Problem 2 2
Display or Visual Feedback Problem 2 2
Loss of Data 2 2
Program or Algorithm Execution Problem 2 2
Disconnection 2 2
Positioning Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 249 249
Insufficient Information 215 215
No Known Impact Or Consequence To Patient 53 53
No Information 44 44
No Consequences Or Impact To Patient 36 36
No Patient Involvement 29 29
Unintended Radiation Exposure 13 13
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 8 8
Bone Fracture(s) 7 7
Incontinence 3 3
Abrasion 3 3
Ambulation Difficulties 2 2
Cancer 2 2
Radiation Burn 2 2
Limb Fracture 2 2
Laceration(s) 2 2
Local Reaction 2 2
Crushing Injury 2 2
No Code Available 2 2
Neuropathy 2 2
Patient Problem/Medical Problem 2 2
Inflammation 1 1
Head Injury 1 1
Atrial Fibrillation 1 1
Necrosis 1 1
Brain Injury 1 1
Injury 1 1
Burn(s) 1 1
Neck Pain 1 1
Foreign Body In Patient 1 1
Radiation Exposure, Unintended 1 1
Nerve Damage 1 1
Diarrhea 1 1
Pleural Effusion 1 1
Hernia 1 1
Viral Infection 1 1
Pain 1 1
Radiodermatitis 1 1
Radiation Underdose 1 1
Not Applicable 1 1
Fall 1 1
Dehydration 1 1
Joint Dislocation 1 1
Swelling/ Edema 1 1
Radiation Overdose 1 1
Melena 1 1
Ulcer 1 1
Unspecified Infection 1 1
Headache 1 1
Constipation 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 Brainlab AG II Mar-16-2023
6 Brainlab AG II Mar-08-2022
7 Brainlab AG II Jun-10-2021
8 Brainlab AG II Mar-08-2021
9 C-RAD POSITIONING AB II Jul-14-2021
10 Carbon Medical Technologies, Inc. III Sep-17-2024
11 ELEKTA SOLUTIONS AB II Oct-14-2021
12 Elekta Limited II Jun-08-2020
13 Elekta Limited II May-08-2019
14 Elekta Limited II Apr-08-2019
15 Elekta Limited II Jan-09-2019
16 Elekta, Inc. II Dec-01-2023
17 Elekta, Inc. II Jun-02-2023
18 Elekta, Inc. II May-30-2023
19 Elekta, Inc. II Oct-14-2021
20 Elekta, Inc. II Sep-29-2021
21 Elekta, Inc. II Jun-02-2021
22 Elekta, Inc. II Jun-30-2020
23 Elekta, Inc. II Jun-05-2020
24 Elekta, Inc. II Aug-09-2019
25 Elekta, Inc. II Jul-16-2019
26 Elekta, Inc. II Feb-08-2019
27 Klarity Medical Products LLC II Aug-24-2020
28 Landauer II Dec-22-2023
29 Landauer II Sep-12-2023
30 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
31 Med Tec Inc II Jun-02-2020
32 Med Tec Inc II Jun-18-2019
33 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
34 PTW NORTH AMERICA CORPORATION II Jan-11-2022
35 PTW-FREIBURG II Feb-22-2024
36 PTW-FREIBURG II Sep-11-2023
37 Reflexion Medical, Inc. II Jan-10-2022
38 Siemens Medical Solutions USA, Inc II Dec-09-2022
39 Siemens Medical Solutions USA, Inc II Dec-29-2021
40 Siemens Medical Solutions USA, Inc II Apr-07-2020
41 Siemens Medical Solutions USA, Inc II Feb-21-2020
42 Siemens Medical Solutions USA, Inc II Aug-06-2019
43 Siemens Medical Solutions USA, Inc II Apr-19-2019
44 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
45 Varian Medical Systems, Inc. II May-05-2020
46 Viewray, Inc. II Nov-20-2020
47 Viewray, Inc. II Apr-27-2020
48 Viewray, Inc. II Dec-12-2019
49 Viewray, Inc. II May-02-2019
50 Zap Surgical Systems II Sep-14-2022
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