|
|
| Device |
accelerator, linear, medical |
| Regulation Description |
Medical charged-particle radiation therapy system. |
| Product Code | IYE |
| Regulation Number |
892.5050
|
|---|
| Device Class |
2
|
| Premarket Reviews |
|---|
| Manufacturer | Decision |
|---|
| ACCURAY INCORPORATED |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| BLESSING CATHAY CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| BRAINLAB AG |
| |
SUBSTANTIALLY EQUIVALENT
|
5
|
| BRAINLAB SE |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CARBON MEDICAL TECHNOLOGIES, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| CARINA MEDICAL, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DOSEOPTICS, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| DOSISOFT SA |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELECTROGENICS LABS, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELEKTA LIMITED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ELEKTA SOLUTIONS AB |
| |
SUBSTANTIALLY EQUIVALENT
|
4
|
| KALLISIO, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| KLARITY MEDICAL & EQUIPMENT (GZ) CO., LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| 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
|
| MEDTEC, INC. DBA CIVCO MEDICAL SOLUTIONS AND CIVCO |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| MICROPOS MEDICAL AB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| NASLUND MEDICAL AB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| OUR UNITED CORPORATION |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PANACEA MEDICAL TECHNOLOGIES PVT. , LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| PAPRICALAB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PROWESS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| PTW-FREIBURG PHYSIKALISCH-TECHNISCHE-WERKSTAETTEN DR. PYCHLA |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
| QFIX |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| RADFORMATION, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
3
|
| SCANDIDOS AB |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| STABILIX, LLC |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VARIAN MEDICAL SYSTEMS |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VARIAN MEDICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
18
|
| VIEWRAY, INCORPORATED |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| VISION RT, LTD. |
| |
SUBSTANTIALLY EQUIVALENT
|
6
|
| WISDOM TECHNOLOGIES., INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
1
|
| ZAP SURGICAL SYSTEMS, INC. |
| |
SUBSTANTIALLY EQUIVALENT
|
2
|
|
| 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 |
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 |
Jan-14-2026 |
| 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, Inc. |
II |
Jan-23-2026 |
| 16 |
Elekta, Inc. |
II |
Jan-13-2026 |
| 17 |
Elekta, Inc. |
II |
Feb-12-2025 |
| 18 |
Elekta, Inc. |
II |
Dec-01-2023 |
| 19 |
Elekta, Inc. |
II |
Jun-02-2023 |
| 20 |
Elekta, Inc. |
II |
May-30-2023 |
| 21 |
Elekta, Inc. |
II |
Oct-14-2021 |
| 22 |
Elekta, Inc. |
II |
Sep-29-2021 |
| 23 |
Elekta, Inc. |
II |
Jun-02-2021 |
| 24 |
IBA Dosimetry GmbH |
II |
Apr-30-2025 |
| 25 |
Landauer |
II |
Dec-22-2023 |
| 26 |
Landauer |
II |
Sep-12-2023 |
| 27 |
Mckesson Medical-Surgical Inc. Corporate Office |
III |
Sep-26-2022 |
| 28 |
PTW NORTH AMERICA CORPORATION |
II |
Jan-11-2022 |
| 29 |
PTW-FREIBURG |
II |
Feb-22-2024 |
| 30 |
PTW-FREIBURG |
II |
Sep-11-2023 |
| 31 |
Reflexion Medical, Inc. |
II |
Jan-10-2022 |
| 32 |
Siemens Medical Solutions USA, Inc |
II |
Dec-09-2022 |
| 33 |
Siemens Medical Solutions USA, Inc |
II |
Dec-29-2021 |
| 34 |
Varian Medical Systems Imaging Laboratory GmbH |
II |
Apr-14-2022 |
| 35 |
Zap Surgical Systems |
II |
Sep-26-2025 |
| 36 |
Zap Surgical Systems |
II |
Sep-14-2022 |
|
|
|
|
