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Company Name Brand Name GMDN Term Name GMDN Term Status FDA Product Code Name FDA Product Code Device Packaged As Sterile Sterilization Prior To Use Issuing Agency Device Size Device Size Type Device Class Implantable

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X-CEL X-RAY CORPORATION - B216HF718BD1

PODIATRY X-RAY MACHINE, 10-18mA, 50-90 kV
ARQUILLA, INC.
HF 718BD
In Commercial Distribution

  • B216HF718BD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216HDRI715A401

TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
HDRI-715A-40
In Commercial Distribution

  • B216HDRI715A401 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216HDR715A401

TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
HDR-715A-40
In Commercial Distribution

  • B216HDR715A401 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216FB910A40K1

PODIATRY X-RAY MACHINE, 10mA, 50-90kV
ARQUILLA, INC.
FB910A-40K
In Commercial Distribution

  • B216FB910A40K1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216FB715NT1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
FB-715NT
In Commercial Distribution

  • B216FB715NT1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216DRH700AC1

TABLE TOP X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
DRH-700 A/C
In Commercial Distribution

  • B216DRH700AC1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216BDXC7001

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
BDXC-700
In Commercial Distribution

  • B216BDXC7001 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715TBD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715T-BD
In Commercial Distribution

  • B216715TBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715SD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715-SD
In Commercial Distribution

  • B216715SD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715RSD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715R-SD
In Commercial Distribution

  • B216715RSD1 ()


  • Stationary basic diagnostic x-ray system, analogue

X-CEL X-RAY CORPORATION - B216715BBD1

PODIATRY X-RAY MACHINE, 15mA, 50-70kV
ARQUILLA, INC.
715B-BD
In Commercial Distribution

  • B216715BBD1 ()


  • Stationary basic diagnostic x-ray system, analogue

TBS iNsight - B214OSTBSIV400

TBS iNsight is a software application provided for use as a complement to bone mineral density (BMD) acquired from dual energy X-ray absorptiometry (DXA) and other clinical risk factors for osteoporosis and fragility fracture. It calculates a score (Trabecular Bone Score - TBS) derived from the texture of the DXA image of the anterior-posterior (AP) lumbar spine and has been shown to be related to bone microarchitecture. The method analyzes X-ray based images acquired by DXA imaging systems and produces the TBS based on the computation of an Adapted Experimental Variogram (modified fractal-like approach). This variogram is used to measure the degree of spatial variation between pairs of data points in a spatial dimension of a region of a digital image.
medimaps group SA
4.0
In Commercial Distribution

  • B214OSTBSIV400 ()


  • Basic diagnostic x-ray system application software

CPI-3 Clinical Programming Interface - 07630016841552

No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016841552 ()


  • Hearing implant implantable-component tester, postoperative

CPI-3 Clinical Programming Interface - 07630016817137

No Description
Advanced Bionics, LLC
CI-6101
Not in Commercial Distribution

  • 07630016817137 ()


  • Hearing implant implantable-component tester, postoperative

Clinician's Programming Interface - 07630016809705

No Description
Advanced Bionics, LLC
AB-6500
Not in Commercial Distribution

  • 07630016809705 ()


  • Hearing implant implantable-component tester, postoperative

DRX - Ascend System - 60889971029881

LONG LENGTH IMAGING SW FOR DRX-ASCEND
CARESTREAM HEALTH, INC.
DRX - Ascend System
Not in Commercial Distribution

  • 60889971029881 ()
1029883

  • Basic diagnostic x-ray system application software

Logicon Caries Detector - 60192156851628

LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM DENTAL LLC
Logicon Caries Detector
Not in Commercial Distribution

  • 60192156851628 ()
8008690

  • General-purpose dental x-ray system application software

Logicon Caries Detector - 60889978008698

LOGICON SITE LIC (UP TO 10) W/IWT
CARESTREAM HEALTH, INC.
Logicon Caries Detector
In Commercial Distribution

  • 60889978008698 ()
8008690

  • General-purpose dental x-ray system application software

CS 3D Imaging Software - 60889975319582

CS 3D IMAGING
CARESTREAM HEALTH, INC.
CS 3D Imaging Software
In Commercial Distribution

  • 60889975319582 ()
5319587

  • General-purpose dental x-ray system application software

Dental Imaging Software - 60889975319575

DENTAL IMAGING SOFTWARE
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889975319575 ()
5319579

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60889975314303

CS IMAGING V7 WINDOWS EDITION
CARESTREAM HEALTH, INC.
CS Imaging Suite
In Commercial Distribution

  • 60889975314303 ()
5314307

  • General-purpose dental x-ray system application software

Dental Imaging Software - 60889971045072

Dental Imaging software update only
CARESTREAM HEALTH, INC.
Dental Imaging Software
In Commercial Distribution

  • 60889971045072 ()
1045079

  • General-purpose dental x-ray system application software

CS Imaging Software V7 - 60889971745927

CS IMAGING V7 update only
CARESTREAM HEALTH, INC.
CS Imaging Software V7
Not in Commercial Distribution

  • 60889971745927 ()
1745926

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155943010

CS IMAGING CLIENT SERVER SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
Not in Commercial Distribution

  • 60192155943010 ()
5943014

  • General-purpose dental x-ray system application software

Logicon Caries Detector - 60192155942754

CSD LOGICON CARIES DETECTOR
CARESTREAM DENTAL LLC
Logicon Caries Detector
In Commercial Distribution

  • 60192155942754 ()
5942750

  • General-purpose dental x-ray system application software

Trophy Imaging 8 - 60192155500688

Trophy Imaging 8
CARESTREAM DENTAL LLC
Trophy Imaging 8
In Commercial Distribution

  • 60192155500688 ()
5500681

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155500671

CS IMAGING 8 SUITE
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155500671 ()
5500673

  • General-purpose dental x-ray system application software

CS 3D Imaging Software - 60192155319587

CS 3D IMAGING
CARESTREAM DENTAL LLC
CS 3D Imaging Software
In Commercial Distribution

  • 60192155319587 ()
5319587

  • General-purpose dental x-ray system application software

Dental Imaging Software - 60192155319570

DENTAL IMAGING SOFTWARE
CARESTREAM DENTAL LLC
Dental Imaging Software
In Commercial Distribution

  • 60192155319570 ()
5319579

  • General-purpose dental x-ray system application software

Trophy 3D Imaging - 60192155319556

TROPHY 3D IMAGING
CARESTREAM DENTAL LLC
Trophy 3D Imaging
In Commercial Distribution

  • 60192155319556 ()
5319553

  • General-purpose dental x-ray system application software

CS Imaging Suite - 60192155314308

CS Imaging Suite
CARESTREAM DENTAL LLC
CS Imaging Suite
In Commercial Distribution

  • 60192155314308 ()
5314307

  • General-purpose dental x-ray system application software

EVASOFT - D83399924908000

EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution

  • D83399924908000 ()
9992490800

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924122050

EVA SELECT SIZE 2 SENSOR
ImageWorks
9992412205
In Commercial Distribution

  • D83399924122050 ()
9992412205

  • General-purpose dental x-ray system application software

EVA SELECT - D83399924121050

EVA SELECT SIZE 1 SENSOR
ImageWorks
9992412105
In Commercial Distribution

  • D83399924121050 ()
9992412105

  • General-purpose dental x-ray system application software

VITOM - 04048551347188

VITOM® II NIR/ICG Telescope 0°
Karl Storz GmbH & Co. KG
20916025AGA
In Commercial Distribution

  • 04048551347188 ()


  • Surgical microscope video camera, sterilizable

VITOM - 04048551241509

VITOM® 25 Telescope 0°, AA 25 - 75 cm
Karl Storz GmbH & Co. KG
20916020
In Commercial Distribution

  • 04048551241509 ()


  • Surgical microscope video camera, sterilizable

Apex Cloud Software - D875403051

A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution

  • D875403051 ()


  • General-purpose dental x-ray system application software

Apex Capture Software - D875400101

Dental imaging capture, enhance and display software.
MASTERLINK LLC
1
In Commercial Distribution

  • D875400101 ()


  • General-purpose dental x-ray system application software

VITOM - 04048551324745

VITOM® Telescope 0° w Integ. Illuminator
Karl Storz GmbH & Co. KG
20916025AA
In Commercial Distribution

  • 04048551324745 ()


  • Surgical microscope video camera, sterilizable

VITOM - 04048551324738

VITOM® Tel. 90° w Integ. Illuminator
Karl Storz GmbH & Co. KG
20916025DA
In Commercial Distribution

  • 04048551324738 ()


  • Surgical microscope video camera, sterilizable

AI-Rad Companion (Pulmonary) - 04056869996172

No Description
Siemens Healthcare GmbH
11665780
In Commercial Distribution

  • 04056869996172 ()


  • CT system application software

syngo.CT Dual Energy - 04056869994536

No Description
Siemens Healthcare GmbH
11664807
In Commercial Distribution

  • 04056869994536 ()


  • CT system application software

syngo.CT Applications - 04056869287416

No Description
Siemens Healthcare GmbH
11546430
In Commercial Distribution

  • 04056869287416 ()


  • CT system application software

syngo.via RT Image Suite - 04056869287393

No Description
Siemens Healthcare GmbH
11546418
In Commercial Distribution

  • 04056869287393 ()


  • CT system application software

syngo.CT Extended Functionality - 04056869287386

No Description
Siemens Healthcare GmbH
11546417
In Commercial Distribution

  • 04056869287386 ()


  • CT system application software

syngo.CT Skull Unfolding - 04056869267463

No Description
Siemens Healthcare GmbH
11546336
In Commercial Distribution

  • 04056869267463 ()


  • CT system application software

syngo.CT Brain Hemorrhage - 04056869267456

No Description
Siemens Healthcare GmbH
11546320
In Commercial Distribution

  • 04056869267456 ()


  • CT system application software

syngo.via RT Image Suite - 04056869267425

No Description
Siemens Healthcare GmbH
11546318
In Commercial Distribution

  • 04056869267425 ()


  • CT system application software

syngo.CT Dual Energy - 04056869267340

No Description
Siemens Healthcare GmbH
11546307
In Commercial Distribution

  • 04056869267340 ()


  • CT system application software

syngo Application Software - 04056869262567

syngo Application Software VD3; covered by NFJ to K170747/K173611 syngo Application Software VD2
Siemens Healthcare GmbH
11328180
In Commercial Distribution

  • 04056869262567 ()


  • Basic diagnostic x-ray system application software
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