1
00628451892021
1
P008943
The Halifax Imaging Kit is part of the SR Suite product line, provides an altern
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The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path tocreating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Raycomponents integrated into an existing digital radiography room already containing an FDAcleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kitand the existing DR system are synchronized by replacing the trigger switches of the twosystems with the Halifax Synchronization Switch. The Halifax Synchronization Switchensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray imagesfrom two different perspectives to be taken at the exact same time. This process allows forRoentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR).RSA is a stereo x-ray technique that enables measurements more accurate and precise thansingle plane radiography based on phantom studies. The increased level of precision enablesmeasurement of implant stability.
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Halifax Imaging Kit
HALIFAX BIOMEDICAL INCORPORATED
2
00195278118356
Tempo
B2401CAB
Definium Tempo System UDI
Definium
HANGWEI GE MEDICAL SYSTEMS CO., LTD.
3
00195278070265
Tempo Pro
B2402CAB
Definium Tempo Pro System UDI
Definium
HANGWEI GE MEDICAL SYSTEMS CO., LTD.
4
B619X200
XPERT 20
specimen x-ray system
KUBTEC
KUBTEC
5
B525ST120
ST-12
Velcro Strap for Ingot
OCTOSTOP INC
6
B525ST110
ST-11
Velcro Strap for Half Ingot
OCTOSTOP INC
7
B525ST050
ST-05
Velcro Strap for Ridges
OCTOSTOP INC
8
B525ST030
ST-03
Velcro Strap For Prism
OCTOSTOP INC
9
B525FIKIT0
FI-KIT
FI-Kit
OCTOSTOP INC
10
B525FI100
FI-10
Internal Rotation Ridges
OCTOSTOP INC
11
B525FI09C0
FI-09C
External Right
OCTOSTOP INC
12
B525FI09B0
FI-09B
Main Inter-Leg Filter
OCTOSTOP INC
13
B525FI09A0
FI-09A
Inter-Thigh Filter
OCTOSTOP INC
14
B525FI090
FI-09
Ridges Plus
OCTOSTOP INC
15
B525FI060
FI-06
Boomerang 15 Degre
OCTOSTOP INC
16
B525FI04A0
FI-04A
Little Prism
OCTOSTOP INC
17
B525FI040
FI-04
Prism
OCTOSTOP INC
18
B525FI03A0
FI-03A
Half Gentle Slope
OCTOSTOP INC
19
B525FI030
FI-03
Gentle Slope
OCTOSTOP INC
20
B525FI02A0
FI-02A
Half Ingot
OCTOSTOP INC
21
B525FI020
FI-02
Ingot
OCTOSTOP INC
22
B525FI01NC0
FI-01NC
Boomerang no Chain
OCTOSTOP INC
23
B525FI01A0
FI-01A
Boomerang with Velcro
OCTOSTOP INC
24
B525FI010
FI-01
Boomerang
OCTOSTOP INC
25
B269SWR00069MD0
SWR-00069-MD
CuattroDR System Software
CuattroDR
CUATTRO MEDICAL
26
B216P700MAC1
P700M A/C
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
27
B216MB715NT1
MB-715NT
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
28
B216LB715NT1
LB-715NT
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
29
B216HF718BD1
HF 718BD
PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
30
B216HDRI715A401
HDRI-715A-40
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
31
B216HDR715A401
HDR-715A-40
TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
32
B216FB910A40K1
FB910A-40K
PODIATRY X-RAY MACHINE, 10mA, 50-90kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
33
B216FB715NT1
FB-715NT
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
34
B216BDXC7001
BDXC-700
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
35
B216715TBD1
715T-BD
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
36
B216715SD1
715-SD
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
37
B216715RSD1
715R-SD
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
38
B216715BBD1
715B-BD
PODIATRY X-RAY MACHINE, 15mA, 50-70kV
X-CEL X-RAY CORPORATION
ARQUILLA, INC.
39
60889978624744
DRX-Compass X-ray System
8624744
X-RAY FMT SYSTEM ANALOG CONSOLE PDU C/F
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
40
60889978624737
DRX-Compass X-ray System
8624736
X-RAY FMT SYSTEM DIGITAL CONSOLE PDU C/F
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
41
60889978624263
CARESTREAM DRX-EVOLUTION Plus
8624264
DRX-EVOLUTION PLUS SYSTEM LOSHPD
CARESTREAM DRX-EVOLUTION Plus
CARESTREAM HEALTH, INC.
42
60889978624256
CARESTREAM DRX-EVOLUTION Plus
8624256
DRX-EVOLUTION PLUS SYSTEM L1741040
CARESTREAM DRX-EVOLUTION Plus
CARESTREAM HEALTH, INC.
43
60889978624249
CARESTREAM DRX-EVOLUTION Plus
8624249
DRX-EVOLUTION PLUS SYSTEM L1741032
CARESTREAM DRX-EVOLUTION Plus
CARESTREAM HEALTH, INC.
44
60889978624218
CARESTREAM DRX-EVOLUTION Plus
8624215
DRX-EVOLUTION PLUS SYSTEM L1739218
CARESTREAM DRX-EVOLUTION Plus
CARESTREAM HEALTH, INC.
45
60889978624201
CARESTREAM DRX-EVOLUTION Plus
8624207
DRX-EVOLUTION PLUS SYSTEM L1739192
CARESTREAM DRX-EVOLUTION Plus
CARESTREAM HEALTH, INC.
46
60889978624195
DRX-Compass X-ray System
8624199
X-RAY SYSTEM CONSOLE PDU 3 P 208-240 C/F
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
47
60889978624188
DRX-Compass X-ray System
8624181
X-RAY SYSTEM CONSOLE PDU 3 P 380-480 C/F
DRX-Compass X-ray System
CARESTREAM HEALTH, INC.
48
60889978622351
NONE
8622359
X-RAY SYSTEM CONSOLE PDU 3P 208-240 C/F
NONE
CARESTREAM HEALTH, INC.
49
60889978621668
Value Systems
8621666
GENERATOR GRP D 50KW 3P 208-240 VAC
Value Systems
CARESTREAM HEALTH, INC.
50
60889978621651
Value Systems
8621658
GENERATOR GRP C 50KW 3P 380-480 VAC
Value Systems
CARESTREAM HEALTH, INC.