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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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SW version VB10B
Siemens Healthcare GmbH
11234870
In Commercial Distribution

  • 04056869012803 ()


  • MRI system application software
OAS Server for VERSEIA Integrated Processor (VIP)
ORTHO-CLINICAL DIAGNOSTICS, INC.
6842840
In Commercial Distribution

  • 10758750012763 ()
6842840

  • Laboratory instrument/analyser application software IVD
OAS Server - 450 MHz, Refurbished
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416F
In Commercial Distribution

  • 10758750005505 ()
936416F

  • Laboratory instrument/analyser application software IVD
OAS Server for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936416
In Commercial Distribution

  • 10758750005499 ()
936416

  • Laboratory instrument/analyser application software IVD
OAS 400 MHz Workstation Refurbished for Summit Sample Handling System
ORTHO-CLINICAL DIAGNOSTICS, INC.
936415F
In Commercial Distribution

  • 10758750005482 ()
936415F

  • Laboratory instrument/analyser application software IVD
Vscan Air R3 for iOS
GE Vingmed Ultrasound AS
Air R3 for iOS
In Commercial Distribution

  • 00195278884749 ()


  • Ultrasound imaging system application software
DE MR Remote Scan Modality Connectivity Executable_1.5.6-RS
GE HEALTHCARE
with Remote scanning for MR
In Commercial Distribution

  • 00195278707741 ()
5941611

  • MRI system application software
Vscan Air R2 Upgrade kit
GE Vingmed Ultrasound AS
Air R2 CL
In Commercial Distribution

  • 00195278640574 ()


  • Ultrasound imaging system application software
Vscan Air R2 for Android
GE Vingmed Ultrasound AS
Air R2 for Android
In Commercial Distribution

  • 00195278640567 ()


  • Ultrasound imaging system application software
Vscan Air R2 for iOS
GE Vingmed Ultrasound AS
Air R2 for iOS
In Commercial Distribution

  • 00195278640550 ()


  • Ultrasound imaging system application software
Vscan Air R3 for Android
GE Vingmed Ultrasound AS
Air R3 for Android
In Commercial Distribution

  • 00195278884725 ()


  • Ultrasound imaging system application software
Venue Sprint R5 MD
Ge Medical Systems, Ultrasound & Primary Care Diagnostics Llc
R5
In Commercial Distribution

  • 00195278754011 ()


  • Ultrasound imaging system application software
DRIVER HF UNIT KLS MARTIN
Richard Wolf GmbH
5592606
Not in Commercial Distribution

  • 04055207057537 ()
5592606

  • Operating room audiovisual data/device management system application software
CHECKLIST APP This app requires core.portal. The checklist app is a universal questionnaire and checklist system for collecting information during surgery. Checklists can be defined as customer-specific multilingual templates. The checklists are displayed in accordance with the language selected in the core.browser. The app generates a PDF report with the demographic patient data, information about the surgical intervention, a logo and the recorded data. The report is part of the documentation. The app does not spread the information collected.
Richard Wolf GmbH
5597706
Not in Commercial Distribution

  • 04055207070086 ()
5597706

  • Operating room audiovisual data/device management system application software
MEDIA ARCHIVE FILESHARE This module requires core.portal. It allows the storage of intraoperative data to an enabled directory in the hospital’s IT infrastructure. The module is required once for each file sharing approval.
Richard Wolf GmbH
5597203
Not in Commercial Distribution

  • 04055207070079 ()
5597203

  • Operating room audiovisual data/device management system application software
CORE.PORTAL SCHEDULING HL7 This module requires core.portal as a basis. It is used for transmitting demographic patient data or surgery scheduling data from a hospital information system via HL7 messages to core.portal. One module is required for each message type.
Richard Wolf GmbH
5597303
Not in Commercial Distribution

  • 04055207070062 ()
5597303

  • Operating room audiovisual data/device management system application software
CORE.PORTAL Establishes the connection between the intra-operative networks and the hospital-wide IT systems.Provides various services centrally in all operating rooms. Included are: Installation service Receiving and forwarding of patient lists by means of DICOM WORKLIST. Receiving and forwarding of images and videos by means of DICOM STORE. Intraoperative management of recorded images and videos using MEDIA ARCHIVE APP. A server, which provides the virtual environment with the ESXi operating system, is required for installation. The server hardware is not part of the Richard Wolf portfolio and must be provided by customers on their own.
Richard Wolf GmbH
5597101
In Commercial Distribution

  • 04055207058848 ()
5597101

  • Operating room audiovisual data/device management system application software
Installation Kit for QVCAD System Release 3.4.6 with Debian 12.2
QVIEW MEDICAL
12.02-3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software
Installation Kit for QVCAD System Release 3.4.4 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software
Installation Kit for QVCAD System Release 3.4.3 with Debian 10.10
QVIEW MEDICAL
10.10-3.4.3
In Commercial Distribution

  • B630QVCSIK1010343 ()


  • Ultrasound imaging system application software
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.6
Not in Commercial Distribution



  • Ultrasound imaging system application software
Computer aided detection system of suspicious lesions in automated breast ultrasound images.
QVIEW MEDICAL
3.4.4
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4.3
In Commercial Distribution

  • B630QVCS343 ()


  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4.2
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.4
In Commercial Distribution



  • Ultrasound imaging system application software
No Description
QVIEW MEDICAL
3.3
In Commercial Distribution

  • B630QVCS33 ()


  • Ultrasound imaging system application software
Visualize:Vascular is software that renders 3D images of vascular segments from ultrasound imaging.
SALIENT IMAGING
1.2
In Commercial Distribution

  • B725INITVV1 ()
  • B725INITVV12 ()
INITVV

  • Ultrasound imaging system application software
BioPlex 2200 HIV Ag-Ab Assay Protocol File CD SW4.3_v5
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563939 ()

  • 1 Each
12001442

  • Laboratory instrument/analyser application software IVD
U.S.IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, US, SW4.3_v5 12001443
BIO-RAD LABORATORIES, INC.
4.3_v5
In Commercial Distribution

  • 03610520563922 ()

  • 1 Each
12001443

  • Laboratory instrument/analyser application software IVD
BioPlex® 2200 HIV Ag-Ab Assay Protocol Files CD SW4.2_v4
BIO-RAD LABORATORIES, INC.
SW4.2_v4
In Commercial Distribution

  • 03610520519813 ()

  • 1 Each
6653475A

  • Laboratory instrument/analyser application software IVD
U.S. IFU, Manual & CDs, BioPlex 2200 HIV Ag-Ab IFU, SW 4.3_v5
BIO-RAD LABORATORIES, INC.
SW4.3_v5
In Commercial Distribution

  • 03610520178904 ()

  • 1 Each
12003844

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450871111 ()
87111

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V7
In Commercial Distribution

  • 03607450867657 ()
86765

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000047 ()
86765

  • Laboratory instrument/analyser application software IVD
No Description
DIAGNOSTICA STAGO
V8
In Commercial Distribution

  • 03607450000030 ()
87111

  • Laboratory instrument/analyser application software IVD
No Description
Quantib B.V.
1.6
In Commercial Distribution

  • 08719689791032 ()


  • MRI system application software
No Description
Quantib B.V.
2.2
In Commercial Distribution

  • 08719689791261 ()


  • MRI system application software
No Description
Quantib B.V.
1.5
In Commercial Distribution

  • 08719689791254 ()


  • MRI system application software
No Description
Quantib B.V.
2.1
In Commercial Distribution

  • 08719689791216 ()


  • MRI system application software
No Description
Quantib B.V.
2.0
In Commercial Distribution

  • 08719689791179 ()


  • MRI system application software
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