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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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Varex Digital Imaging Software, Nexus DRF, v3.5 - 00810751030252

No Description
VAREX IMAGING CORPORATION
Nexus DRF v3.5
In Commercial Distribution

  • 00810751030252 ()


  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-FM - 60889976573341

QG-TV10-IPF-MAT TECHVISION QS-550 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-FM
In Commercial Distribution

  • 60889976573341 ()
6573349

  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-CM - 60889976573327

QG-TV10-IPC-MAT TECHVISION RS-590 DRX AT
CARESTREAM HEALTH, INC.
QG-TV-IP-CM
In Commercial Distribution

  • 60889976573327 ()
6573323

  • X-ray system computer, diagnostic, general-purpose

QG-TV-FM - 60889976573303

QG-TV10-F-MAT TECHVISION QS-550 Q-VISION
CARESTREAM HEALTH, INC.
QG-TV-FM
In Commercial Distribution

  • 60889976573303 ()
6573307

  • X-ray system computer, diagnostic, general-purpose

QG-TV-F - 60889976573297

QG-TV10-F TECHVISION QS-550 WITH Q-VISIO
CARESTREAM HEALTH, INC.
QG-TV-F
In Commercial Distribution

  • 60889976573297 ()
6573299

  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-C - 60889971065391

Techvision for Ceiling Systm
CARESTREAM HEALTH, INC.
QG-TV-IP-C
In Commercial Distribution

  • 60889971065391 ()
1065390

  • X-ray system computer, diagnostic, general-purpose

DRX - Ascend System - 60889976574645

QG-TV-CM
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976574645 ()
6574644

  • X-ray system computer, diagnostic, general-purpose

DRX - Ascend System - 60889976574638

QG-TV10-C TECHVISION RS-590 WITH Q-VISIO
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976574638 ()
6574636

  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-F - 60889976573334

QG-TV10-IPF TECHVISION QS-550 WITH DRX
CARESTREAM HEALTH, INC.
QG-TV-IP-F
In Commercial Distribution

  • 60889976573334 ()
6573331

  • X-ray system computer, diagnostic, general-purpose

QG-TV-IP-C - 60889976573310

QG-TV10-IPC TECHVISION RS-590 WITH DRX
CARESTREAM HEALTH, INC.
QG-TV-IP-C
In Commercial Distribution

  • 60889976573310 ()
6573315

  • X-ray system computer, diagnostic, general-purpose

DRX - Ascend System - 60889976571866

TECHVISIN SYSTM,RS-590 WIT
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889976571866 ()
6571863

  • X-ray system computer, diagnostic, general-purpose

DRX - Ascend System - 60889974005226

TECHVISION FOR CEILING SYSTEM
CARESTREAM HEALTH, INC.
DRX - Ascend System
In Commercial Distribution

  • 60889974005226 ()
1025907

  • X-ray system computer, diagnostic, general-purpose

Isansys - 05060488680304

Data entry & local display point tablet computer, 10.5 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway SM-X200 – 10.5 - WiFi
In Commercial Distribution

  • 05060488680304 ()
Gateway SM-X200 – 10.5 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680267

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T515 - 10.1 - GSM
In Commercial Distribution

  • 05060488680267 ()
Gateway T515 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680250

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T510 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680250 ()
Gateway T510 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680205

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - GSM
In Commercial Distribution

  • 05060488680205 ()
Patient Gateway T580 - 10.1 - GSM

  • Physiological measuring device wireless data capture/transfer unit

Isansys - 05060488680182

Data entry & local display point tablet computer, 10.1 Screen
ISANSYS LIFECARE LIMITED
Patient Gateway T580 - 10.1 - WiFi
In Commercial Distribution

  • 05060488680182 ()
Gateway T580 - 10.1 - WiFi

  • Physiological measuring device wireless data capture/transfer unit

N/A - 00851725007153

Remote Network Station with Dell OptiPlex 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-7450
In Commercial Distribution

  • 00851725007153 ()
RNS-6803-7450

  • Centralized patient monitor

N/A - 00851725007139

Remote Network Station with Dell Inspiron 24” All-In-One Computer
Nihon Kohden Digital Health Solutions, LLC
RNS-6803-3464
In Commercial Distribution

  • 00851725007139 ()
RNS-6803-3464

  • Centralized patient monitor

SeeMore - 00850921007035

USB ultrasound probe, general purpose/abdominal, with tablet computer
INTERSON CORP
ViewBladder 10
In Commercial Distribution

  • 00850921007035 ()
99-9008

  • Extracorporeal ultrasound imaging transducer, hand-held

NA - 00841983104176

Remote Network Station with Dell OptiPlex 7460 All-In-One Computer
NIHON KOHDEN AMERICA, INC.
RNS-6803-7460
Not in Commercial Distribution

  • 00841983104176 ()
RNS-6803-7460

  • Centralized patient monitor

ThinPrep Imaging System - 15420045515062

Computer to operate the ThinPrep® Review Scope Manual+.
Hologic, Inc.
ThinPrep Imaging System Computer
In Commercial Distribution

  • 15420045515062 ()
CMP-01836

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045512535

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045512535 ()
ASY-13755

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045507265

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045507265 ()
ASY-10745

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504103

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504103 ()
ASY-08346

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504097

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504097 ()
ASY-06281

  • Laboratory instrument/analyser application software IVD

ThinPrep Imaging System - 15420045504080

Computer to operate the ThinPrep® Imager DUO System.
Hologic, Inc.
ThinPrep Imaging System Workstation
In Commercial Distribution

  • 15420045504080 ()
ASY-06284

  • Laboratory instrument/analyser application software IVD

Image filing software NAVIS-EX - 04987669200636

The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
NIDEK CO.,LTD.
1.12
In Commercial Distribution

  • 04987669200636 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software

Image filing software - 04987669100523

The NAVIS-EX image filing software is software that acquires data from the following NIDEK fundus photography devices and files it for easy transfer to external systems. NAVIS-EX is equipped with functions for image acquiring, image display, image drawing, image processing, image measurement, panorama image creation, stereo image observation, composite image creation, and Follow-Up. (According to the image, available functions are limited.) Image data can be transferred by network or e-mail. NAVIS-EX can construct a network among multiple terminals and refers to and edits data from the client PC.
NIDEK CO.,LTD.
NAVIS-EX
In Commercial Distribution

  • 04987669100523 ()


  • Eye anterior segment analyser software
  • Posterior eye segment analyser software

JointVue 3D Echo - 00850014885007

3D Echo Software
JOINTVUE, LLC
1.0
Not in Commercial Distribution

  • 00850014885007 ()


  • Ultrasound imaging system operation software

IlluminatusDXA Software - 00866955000478

No Description
Norland at Swissray
4
In Commercial Distribution

  • 00866955000478 ()


  • Basic diagnostic x-ray system operation software

4D View - 00840682102780

No Description
GE Healthcare Austria GmbH & Co OG
16
In Commercial Distribution

  • 00840682102780 ()


  • Ultrasound imaging system operation software

4D View - 00840682137621

No Description
GE Healthcare Austria GmbH & Co OG
18
In Commercial Distribution

  • 00840682137621 ()


  • Ultrasound imaging system operation software

4D View - 00840682122788

No Description
GE Healthcare Austria GmbH & Co OG
17
In Commercial Distribution

  • 00840682122788 ()


  • Ultrasound imaging system operation software

Dornier MedTech - 04049957000578

UIMS Viewing Station SC High Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000578 ()
K1029226

  • Basic diagnostic x-ray system operation software

Dornier MedTech - 04049957000561

UIMS Viewing Station SC Low Line
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000561 ()
K1029225

  • Basic diagnostic x-ray system operation software

Dornier MedTech - 04049957000554

UIMS Viewing Station
Dornier MedTech GmbH
UIMS
In Commercial Distribution

  • 04049957000554 ()
K1028986

  • Basic diagnostic x-ray system operation software

ClearSteth - 00850033167108

Digital stethoscope and hosted software application solution.
Globalmed Holdings, LLC
GSW30100103
In Commercial Distribution

  • 00850033167108 ()
GSW30100103

  • Stethoscope application software

3M™ Littmann® - 00707387779054

Littmann® Stethassist Heart And Lung Sound Visualization Software
3M COMPANY
ES1000
In Commercial Distribution

  • 00707387779054 ()
ES1000

  • Stethoscope application software

Littmann® Telesteth™ - 00707387766597

TS1200CL TELESTETH SOFTWARE HOSTED LICENSE
3M COMPANY
TS1200CL
In Commercial Distribution

  • 00707387766597 ()
TS1200CL

  • Stethoscope application software

HUMAC Biodex System4 - 00860139000360

HUMAC Biodex System4 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503680
In Commercial Distribution

  • 00860139000360 ()
503680

  • Back/leg/chest dynamometer

HUMAC Biodex System3 Rev1 (R) - 00860139000353

HUMAC Biodex System3 Rev1 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503679
In Commercial Distribution

  • 00860139000353 ()
503679

  • Back/leg/chest dynamometer

HUMAC Biodex System3 Rev0 (R) - 00860139000346

HUMAC Biodex System3 Rev0 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503678
In Commercial Distribution

  • 00860139000346 ()
503678

  • Back/leg/chest dynamometer

HUMAC Biodex System2 (R) - 00860139000339

HUMAC Biodex System2 Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
503677
In Commercial Distribution

  • 00860139000339 ()
503677

  • Back/leg/chest dynamometer

HUMAC Cybex NORM (R) - 00860139000322

HUMAC Cybex NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504192
In Commercial Distribution

  • 00860139000322 ()
504192

  • Back/leg/chest dynamometer

HUMAC NORM (R) - 00860139000315

HUMAC NORM Extremity System; Dynamometer – Refurbished
COMPUTER SPORTS MEDICINE INC.
504191
In Commercial Distribution

  • 00860139000315 ()
504191

  • Back/leg/chest dynamometer

HUMAC NORM - 00860139000308

HUMAC NORM Extremity System; Dynamometer
COMPUTER SPORTS MEDICINE INC.
502140
In Commercial Distribution

  • 00860139000308 ()
502140-00

  • Back/leg/chest dynamometer

BBCS Lab Interface Application V5.0 - 00860009119482

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119482 ()


  • Blood bank information system application software

Blood Bank Control System, V5.0 - 00860009119475

No Description
Blood Bank Computer System
5.0
In Commercial Distribution

  • 00860009119475 ()


  • Blood bank information system application software

BBCS Hospital Interface Application - 00860009119468

No Description
Blood Bank Computer System
1.0.0
In Commercial Distribution

  • 00860009119468 ()


  • Blood bank information system application software
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