Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • 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 accelerator, linear, medical
Regulation Description Medical charged-particle radiation therapy system.
Product CodeIYE
Regulation Number 892.5050
Device Class 2


Premarket Reviews
ManufacturerDecision
ACCURAY INCORPORATED
  SUBSTANTIALLY EQUIVALENT 3
AKTINA MEDICAL CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BLESSING CATHAY CORPORATION
  SUBSTANTIALLY EQUIVALENT 1
BRAINLAB AG
  SUBSTANTIALLY EQUIVALENT 8
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
ELECTROGENICS LABS, LTD
  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 3
LANDAUER
  SUBSTANTIALLY EQUIVALENT 1
LAP GMBH LASER APPLIKATIONEN
  SUBSTANTIALLY EQUIVALENT 2
LINATECH LLC
  SUBSTANTIALLY EQUIVALENT 1
MACROMEDICS BV
  SUBSTANTIALLY EQUIVALENT 4
MAGNETTX ONCOLOGY SOLUTIONS LTD.
  SUBSTANTIALLY EQUIVALENT 1
MANTEIA TECHNOLOGIES CO., LTD.
  SUBSTANTIALLY EQUIVALENT 2
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
  SUBSTANTIALLY EQUIVALENT 1
VARIAN MEDICAL SYSTEMS INC.
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC
  SUBSTANTIALLY EQUIVALENT 6
VARIAN MEDICAL SYSTEMS, INC.
  SUBSTANTIALLY EQUIVALENT 9
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 2

MDR Year MDR Reports MDR Events
2019 91 91
2020 74 74
2021 68 69
2022 66 66
2023 128 128
2024 81 81
2025 95 95

Device Problems MDRs with this Device Problem Events in those MDRs
Computer Software Problem 315 315
Use of Device Problem 30 30
Adverse Event Without Identified Device or Use Problem 26 26
Detachment of Device or Device Component 21 21
Unintended System Motion 19 19
Imprecision 18 18
Device Handling Problem 12 12
Fluid/Blood Leak 11 11
Unintended Movement 10 10
Unstable 9 9
Break 9 9
No Apparent Adverse Event 8 8
Communication or Transmission Problem 8 9
Insufficient Information 8 8
Improper or Incorrect Procedure or Method 7 7
Data Problem 7 7
Application Program Problem: Dose Calculation Error 7 7
Application Program Problem 7 7
Unintended Collision 6 6
Material Deformation 6 6
Off-Label Use 6 6
Mechanical Problem 6 6
Output Problem 4 4
Device Fell 4 4
Protective Measures Problem 4 5
Therapeutic or Diagnostic Output Failure 4 4
Installation-Related Problem 4 4
Electrical /Electronic Property Problem 4 4
Labelling, Instructions for Use or Training Problem 4 4
Low impedance 3 3
Inadequate User Interface 3 3
Therapy Delivered to Incorrect Body Area 3 3
Defective Component 3 3
Material Integrity Problem 3 3
Radiation Overexposure 3 3
Intermittent Communication Failure 3 3
Grounding Malfunction 3 3
Use of Incorrect Control/Treatment Settings 3 3
Calibration Problem 3 3
Human-Device Interface Problem 3 3
Patient-Device Incompatibility 2 2
Circuit Failure 2 2
Failure to Recalibrate 2 2
Disconnection 2 2
Positioning Problem 2 2
Appropriate Term/Code Not Available 2 2
Compatibility Problem 2 2
Program or Algorithm Execution Problem 2 2
Display or Visual Feedback Problem 2 2
Retraction Problem 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 310 310
Insufficient Information 291 292
No Known Impact Or Consequence To Patient 53 53
No Information 44 44
No Consequences Or Impact To Patient 36 36
Unintended Radiation Exposure 31 31
No Patient Involvement 29 29
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 13 13
Bone Fracture(s) 8 8
Incontinence 4 4
Abrasion 3 3
Ambulation Difficulties 2 2
Cancer 2 2
Ulcer 2 2
Radiation Burn 2 2
Limb Fracture 2 2
Laceration(s) 2 2
Foreign Body In Patient 2 2
Local Reaction 2 2
Crushing Injury 2 2
Head Injury 2 2
No Code Available 2 2
Patient Problem/Medical Problem 2 2
Neuropathy 2 2
Atrial Fibrillation 1 1
Inflammation 1 1
Necrosis 1 1
Burn(s) 1 1
Injury 1 1
Neck Pain 1 1
Diarrhea 1 1
Nerve Damage 1 1
Pleural Effusion 1 1
Vomiting 1 1
Hernia 1 1
Viral Infection 1 1
Not Applicable 1 1
Radiation Exposure, Unintended 1 1
Dehydration 1 1
Fall 1 1
Brain Injury 1 1
Pain 1 1
Radiation Underdose 1 1
Radiodermatitis 1 1
Nausea 1 1
Swelling/ Edema 1 1
Radiation Overdose 1 1
Joint Dislocation 1 1
Melena 1 1
Headache 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Accuray Incorporated II Jan-27-2025
2 Accuray Incorporated II Aug-31-2023
3 Accuray Incorporated II Mar-17-2021
4 Accuray Incorporated II Jan-07-2021
5 Accuray Incorporated II Jun-01-2019
6 Brainlab AG II Mar-16-2023
7 Brainlab AG II Mar-08-2022
8 Brainlab AG II Jun-10-2021
9 Brainlab AG II Mar-08-2021
10 C-RAD POSITIONING AB II May-28-2025
11 C-RAD POSITIONING AB II Jul-14-2021
12 Carbon Medical Technologies, Inc. III Sep-17-2024
13 ELEKTA SOLUTIONS AB II Nov-14-2025
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, Inc. II Feb-12-2025
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 IBA Dosimetry GmbH II Apr-30-2025
32 Klarity Medical Products LLC II Aug-24-2020
33 Landauer II Dec-22-2023
34 Landauer II Sep-12-2023
35 Mckesson Medical-Surgical Inc. Corporate Office III Sep-26-2022
36 Med Tec Inc II Jun-02-2020
37 Med Tec Inc II Jun-18-2019
38 Medical Intelligence Medizintechnik Gmbh II Jul-25-2019
39 PTW NORTH AMERICA CORPORATION II Jan-11-2022
40 PTW-FREIBURG II Feb-22-2024
41 PTW-FREIBURG II Sep-11-2023
42 Reflexion Medical, Inc. II Jan-10-2022
43 Siemens Medical Solutions USA, Inc II Dec-09-2022
44 Siemens Medical Solutions USA, Inc II Dec-29-2021
45 Siemens Medical Solutions USA, Inc II Apr-07-2020
46 Siemens Medical Solutions USA, Inc II Feb-21-2020
47 Siemens Medical Solutions USA, Inc II Aug-06-2019
48 Siemens Medical Solutions USA, Inc II Apr-19-2019
49 Varian Medical Systems Imaging Laboratory GmbH II Apr-14-2022
50 Varian Medical Systems, Inc. II May-05-2020
51 Viewray, Inc. II Nov-20-2020
52 Viewray, Inc. II Apr-27-2020
53 Viewray, Inc. II Dec-12-2019
54 Viewray, Inc. II May-02-2019
55 Zap Surgical Systems II Sep-26-2025
56 Zap Surgical Systems II Sep-14-2022
-
-