|
Device |
system, applicator, radionuclide, remote-controlled |
Product Code | JAQ |
Regulation Number |
892.5700
|
Device Class |
2
|
Premarket Reviews |
Manufacturer | Decision |
BEST MEDICAL INTERNATIONAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
BRAXX BIOTECH CO. LTD |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
C4 IMAGING LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIANNA MEDICAL |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CIANNA MEDICAL, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
ECKERT & ZIEGLER BEBIG GMBH |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
GC MEDTECH, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
GEOMED MEDIZIN-TECHNIK GMBH & CO. KG |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
HOLOGIC, INC. |
|
SE - WITH LIMITATIONS
|
2
|
ICAD, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
KOBOLD, LLC |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
MICK RADIO-NUCLEAR INSTRUMENTS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
5
|
NUCLETRON |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUCLETRON B.V. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
NUCLETRON BV |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
NUCLETRON CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
NUCLETRON CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
PHOTON TECHNOLOGIES CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADIADYNE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RADIADYNE, LLC (SPECIFICATION DEVELOPER) |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SENORX, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SPENCER FILLMORE |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
VARIAN MEDICAL SYSTEMS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
VARIAN MEDICAL SYSTEMS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
VARIAN MEDICAL SYSTEMS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
25
|
VIVARAY, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
|
Recalls |
Manufacturer |
Recall Class |
Date Posted |
1 |
Nucletron BV |
II |
Jan-02-2020 |
2 |
Siemens Medical Solutions USA, Inc |
II |
Jun-01-2009 |
3 |
Varian Medical Systems Inc |
II |
Jun-26-2015 |
4 |
Varian Medical Systems Inc |
II |
Jun-23-2015 |
5 |
Varian Medical Systems, Inc. |
II |
Oct-24-2013 |
6 |
Varian Medical Systems, Inc. |
II |
May-15-2013 |
7 |
Varian Medical Systems, Inc. |
II |
Jan-31-2013 |
8 |
Varian Medical Systems, Inc. |
II |
Dec-20-2012 |
9 |
Varian Medical Systems, Inc. |
II |
Mar-12-2012 |
10 |
Varian Medical Systems, Inc. |
II |
Dec-01-2011 |
11 |
Varian Medical Systems, Inc. |
II |
Dec-01-2011 |
12 |
Varian Medical Systems, Inc. |
II |
Nov-30-2011 |
13 |
Varian Medical Systems, Inc. |
II |
Nov-23-2011 |
14 |
Varian Medical Systems, Inc. Oncology Systems |
II |
Dec-01-2011 |
15 |
Varian Medical Systems, Inc. Oncology Systems |
II |
Aug-22-2011 |
16 |
Varian Medical Systems, Inc. Oncology Systems |
II |
Aug-12-2011 |
17 |
Varian Medical Systems, Inc. Oncology Systems |
II |
Aug-11-2011 |
18 |
Varian Medical Systems, Inc. Oncology Systems |
II |
Aug-10-2011 |
|
|
|
|