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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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ENDOPRO STANDALONEC CAPTURE WORKSTATION - 04961333248025

ENDOPRO CAPTURE WORKSTATION, STANDALONE
PENTAX OF AMERICA, INC.
KBM68346
In Commercial Distribution

  • 04961333248025 ()


  • Medical image management system

ENDOPRO NETWORK CAPTURE WORKSTATION - 04961333248018

ENDOPRO CAPTURE WORKSTATION, NETWORK
PENTAX OF AMERICA, INC.
KBM68345
In Commercial Distribution

  • 04961333248018 ()


  • Medical image management system

ENDOPRO REVIEW WORKSTATION - 04961333248001

ENDOPRO REVIEW WORKSTATION
PENTAX OF AMERICA, INC.
KBM68344
In Commercial Distribution

  • 04961333248001 ()
NA

  • Medical image management system

N/A - 04961333245314

MS SQL ENT - 8 CORE LIC (RUNTIME)
PENTAX OF AMERICA, INC.
MSSQL-E8
In Commercial Distribution

  • 04961333245314 ()
  • 14961333245311 ()


  • Radiology information system

N/A - 04961333245307

MS SQL ENT - 4 CORE LIC (RUNTIME)
PENTAX OF AMERICA, INC.
MSSQL-E4
In Commercial Distribution

  • 04961333245307 ()
  • 14961333245304 ()


  • Radiology information system

N/A - 04961333245291

STANDALONE IMAGE CAPTURE PC
PENTAX OF AMERICA, INC.
KBM68407
In Commercial Distribution

  • 04961333245291 ()


  • Radiology information system

Iradimed - 00856038001218

MRI Monitor Remote Base/Charger
IRADIMED CORP.
3885B
In Commercial Distribution

  • 00856038001218 ()
3885B

  • Centralized patient monitor

ZOLL Arrhythmia Management System - 00855778005463

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005463 ()
10A1112

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005456

No Description
ZOLL MANUFACTURING CORPORATION
Gateway (4G)
In Commercial Distribution

  • 00855778005456 ()
10A1107

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005364

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005364 ()
10A1088

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Arrhythmia Management System - 00855778005357

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005357 ()
10A1087

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005326

No Description
ZOLL MANUFACTURING CORPORATION
Gateway
In Commercial Distribution

  • 00855778005326 ()
10A1073

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Charger - 00855778005319

No Description
ZOLL MANUFACTURING CORPORATION
Charger
In Commercial Distribution

  • 00855778005319 ()
10A1072

  • Wearable multiple vital physiological parameter monitoring system

uCor Heart Failure and Arrhythmia Management System - 00855778005302

No Description
ZOLL MANUFACTURING CORPORATION
Sensor
In Commercial Distribution

  • 00855778005302 ()
10A1071

  • Wearable multiple vital physiological parameter monitoring system

ZOLL Patch - 00855778005258

No Description
ZOLL MANUFACTURING CORPORATION
Patch
In Commercial Distribution

  • 00855778005258 ()
10A1067

  • Wearable multiple vital physiological parameter monitoring system

ScanNav Anatomy Peripheral Nerve Block - 05060878810052

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V2.0
Not in Commercial Distribution

  • 05060878810052 ()


  • Ultrasound imaging system application software

ScanNav Anatomy Peripheral Nerve Block - 05060878810021

ScanNav Anatomy Peripheral Nerve Block (Anatomy PNB) is a software as a medical device (SaMD) which assists qualified healthcare professionals to identify anatomy in live ultrasound images. The Anatomy PNB receives scan images in real-time from a compatible general-purpose ultrasound machine. It then processes the images using deep learning artificial intelligence algorithms and highlights relevant anatomical structures on the Anatomy PNB user interface. The original view from the ultrasound machine is not affected and is always available both on the ultrasound machine and the Anatomy PNB.
INTELLIGENT ULTRASOUND LIMITED
V1.1
Not in Commercial Distribution

  • 05060878810021 ()


  • Ultrasound imaging system application software

AI4CMR - 05600250059022

AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion Indications for use: AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making. The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution

  • 05600250059022 ()


  • MRI system application software

Tempus IC - 05060472440686

12-Lead ECG Harness
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1010
Not in Commercial Distribution

  • 05060472440686 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC - 05060472440679

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1001
Not in Commercial Distribution

  • 05060472440679 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440655

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1007
Not in Commercial Distribution

  • 05060472440655 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440648

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1006
Not in Commercial Distribution

  • 05060472440648 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440631

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1005
Not in Commercial Distribution

  • 05060472440631 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440624

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-1004
Not in Commercial Distribution

  • 05060472440624 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440617

USB Serial Inline Converter Cable
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2112
Not in Commercial Distribution

  • 05060472440617 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC - 05060472440600

Lo-Flo® Sidestream Capnometer
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1005
Not in Commercial Distribution

  • 05060472440600 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440594

Tempus Lithium-ion Battery (Orange)
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2029
In Commercial Distribution

  • 05060472440594 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440501

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-T
Not in Commercial Distribution

  • 05060472440501 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440495

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-S
Not in Commercial Distribution

  • 05060472440495 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440488

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
00-2001-R
Not in Commercial Distribution

  • 05060472440488 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440464

Tempus 12-Lead Electrocardiogram Harness
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2001
In Commercial Distribution

  • 05060472440464 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440457

Glucometer Replenishment Kit
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2020
Not in Commercial Distribution

  • 05060472440457 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440440

Consumables Replenishment Kit
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2099
Not in Commercial Distribution

  • 05060472440440 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus IC2 - 05060472440433

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2506
Not in Commercial Distribution

  • 05060472440433 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440419

No Description
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2501
In Commercial Distribution

  • 05060472440419 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440389

Tempus Pro Vehicle Adapter
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2053
Not in Commercial Distribution

  • 05060472440389 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440310

Battery Charger
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-1012
Not in Commercial Distribution

  • 05060472440310 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440303

Mains Power Supply
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2049
Not in Commercial Distribution

  • 05060472440303 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440297

Tempus Lithium-Ion Battery (Black)
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2051
In Commercial Distribution

  • 05060472440297 ()


  • Multiple vital physiological parameter monitoring system, clinical

Tempus Pro - 05060472440280

Tempus Pro 3-Lead Neonatal ECG Cable (AAMI) 6ft
REMOTE DIAGNOSTIC TECHNOLOGIES LIMITED
01-2203
In Commercial Distribution

  • 05060472440280 ()


  • Multiple vital physiological parameter monitoring system, clinical
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