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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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OrthoNext™ Platform System Software - 18052469476451

POSTOPERATIVE MOBILE PATIENT APPLICATION SW
ORTHOFIX SRL
1.0
In Commercial Distribution

  • 18052469476451 ()
MYHEXPLANSW

  • Radiological PACS software

DentalEye - 07350111570026

No Description
Dentaleye AB
Viewer
In Commercial Distribution

  • 07350111570026 ()


  • Radiological PACS software

DentalEye - 07350111570019

No Description
Dentaleye AB
PRO
In Commercial Distribution

  • 07350111570019 ()


  • Radiological PACS software

QbTest - 07350103930067

No Description
Qbtech AB
QbTest
In Commercial Distribution

  • 07350103930067 ()


  • Psychological assessment software

QbCheck - 07350103930012

No Description
Qbtech AB
QbCheck
In Commercial Distribution

  • 07350103930012 ()


  • Psychological assessment software

MRI Planner - 07350097430017

MRI Planner is a stand alone software product intended to enable a completely MRI only workflow in radiotherapy planning. The MRI Planner software achieves this by analyzing a dedicated MR image and generating a synthetic CT image that can replace the conventional CT in the treatment planning process. In addition, the software also performs automated contouring of risk organs in certain anatomies. In the current version of MRI Planner, synthetic CT generation is supported for the brain, head-neck and pelvis anatomies, whereas automated risk organ contouring is supported for bladder, colon and femoral heads for prostate cancer patients only.
Spectronic Medical AB
2
In Commercial Distribution

  • 07350097430017 ()


  • Radiation therapy software

RayStation - 07350002010884

No Description
Raysearch Laboratories AB (Publ)
2024A SP3
In Commercial Distribution

  • 07350002010884 ()


  • Radiation therapy software

RayStation - 07350002010730

No Description
Raysearch Laboratories AB (Publ)
12A SP2
In Commercial Distribution

  • 07350002010730 ()


  • Radiation therapy software

RayStation - 07350002010679

No Description
Raysearch Laboratories AB (Publ)
12A SP1
In Commercial Distribution

  • 07350002010679 ()


  • Radiation therapy software

RayStation - 07350002010570

No Description
Raysearch Laboratories AB (Publ)
11B SPT1
In Commercial Distribution

  • 07350002010570 ()


  • Radiation therapy software

RayStation - 07350002010556

No Description
Raysearch Laboratories AB (Publ)
2023B
In Commercial Distribution

  • 07350002010556 ()


  • Radiation therapy software

RayStation - 07350002010549

No Description
Raysearch Laboratories AB (Publ)
12A
In Commercial Distribution

  • 07350002010549 ()


  • Radiation therapy software

RayStation - 07350002010501

No Description
Raysearch Laboratories AB (Publ)
11B SP2
In Commercial Distribution

  • 07350002010501 ()


  • Radiation therapy software

RayStation - 07350002010495

No Description
Raysearch Laboratories AB (Publ)
11B SP1
In Commercial Distribution

  • 07350002010495 ()


  • Radiation therapy software

RayStation - 07350002010471

No Description
Raysearch Laboratories AB (Publ)
10B SP1
In Commercial Distribution

  • 07350002010471 ()


  • Radiation therapy software

RayStation - 07350002010440

No Description
Raysearch Laboratories AB (Publ)
11A SP2
In Commercial Distribution

  • 07350002010440 ()


  • Radiation therapy software

RayStation - 07350002010433

No Description
Raysearch Laboratories AB (Publ)
11.0.1
In Commercial Distribution

  • 07350002010433 ()


  • Radiation therapy software

RayStation - 07350002010426

No Description
Raysearch Laboratories AB (Publ)
11B
In Commercial Distribution

  • 07350002010426 ()


  • Radiation therapy software

RayStation - 07350002010389

No Description
Raysearch Laboratories AB (Publ)
11.0
In Commercial Distribution

  • 07350002010389 ()


  • Radiation therapy software

RayStation - 07350002010365

No Description
Raysearch Laboratories AB (Publ)
10.0.1
In Commercial Distribution

  • 07350002010365 ()


  • Radiation therapy software

RayStation - 07350002010310

No Description
Raysearch Laboratories AB (Publ)
10.1
In Commercial Distribution

  • 07350002010310 ()


  • Radiation therapy software

RayStation - 07350002010303

No Description
Raysearch Laboratories AB (Publ)
10.0
In Commercial Distribution

  • 07350002010303 ()


  • Radiation therapy software

RayStation - 07350002010297

No Description
Raysearch Laboratories AB (Publ)
9B SP1
In Commercial Distribution

  • 07350002010297 ()


  • Radiation therapy software

RayStation - 07350002010235

No Description
Raysearch Laboratories AB (Publ)
8.1.2
In Commercial Distribution

  • 07350002010235 ()


  • Radiation therapy software

RayStation - 07350002010204

No Description
Raysearch Laboratories AB (Publ)
8.1.1
In Commercial Distribution

  • 07350002010204 ()


  • Radiation therapy software

RayStation - 07350002010174

No Description
Raysearch Laboratories AB (Publ)
9
In Commercial Distribution

  • 07350002010174 ()


  • Radiation therapy software

RayStation - 07350002010136

No Description
Raysearch Laboratories AB (Publ)
8.0.1
In Commercial Distribution

  • 07350002010136 ()


  • Radiation therapy software

RayStation - 07350002010129

No Description
Raysearch Laboratories AB (Publ)
8.1
In Commercial Distribution

  • 07350002010129 ()


  • Radiation therapy software

RayStation - 07350002010112

No Description
Raysearch Laboratories AB (Publ)
8.0
In Commercial Distribution

  • 07350002010112 ()


  • Radiation therapy software

RayStation - 07350002010082

No Description
Raysearch Laboratories AB (Publ)
6.1.1
In Commercial Distribution

  • 07350002010082 ()


  • Radiation therapy software

RayStation - 07350002010075

No Description
Raysearch Laboratories AB (Publ)
6.2
In Commercial Distribution

  • 07350002010075 ()


  • Radiation therapy software

RayStation - 07350002010068

No Description
Raysearch Laboratories AB (Publ)
7
In Commercial Distribution

  • 07350002010068 ()


  • Radiation therapy software

RayStation - 07350002010037

No Description
Raysearch Laboratories AB (Publ)
6.1
In Commercial Distribution

  • 07350002010037 ()


  • Radiation therapy software

RayStation - 07350002010020

No Description
Raysearch Laboratories AB (Publ)
5.0.3
In Commercial Distribution

  • 07350002010020 ()


  • Radiation therapy software

RayStation - 07350002010013

No Description
Raysearch Laboratories AB (Publ)
6.0
In Commercial Distribution

  • 07350002010013 ()


  • Radiation therapy software

AQUA - 07340201500101

No Description
Elekta Solutions AB
AQUA 3.2
In Commercial Distribution

  • 07340201500101 ()


  • Radiation therapy software

Monaco - 07340201500064

No Description
Elekta Solutions AB
6.2
In Commercial Distribution

  • 07340201500064 ()


  • Radiation therapy software

ProKnow DS - 07340201500057

No Description
Elekta Solutions AB
2.0
In Commercial Distribution

  • 07340201500057 ()


  • Radiological PACS software

AATMA - 07340201500040

No Description
Elekta Solutions AB
AATMA
In Commercial Distribution

  • 07340201500040 ()


  • Radiological PACS software

Monaco - 07340201500033

No Description
Elekta Solutions AB
Monaco
In Commercial Distribution

  • 07340201500033 ()


  • Radiation therapy software
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