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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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LUNA 3D - 04260590372673

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372673 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372666

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372666 ()
0018438

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372659

No Description
L A P GMBH LASER APPLIKATIONEN
Central Server host PC Luna 3D
In Commercial Distribution

  • 04260590372659 ()
0018439-0001

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372635

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA SGRT PC
In Commercial Distribution

  • 04260590372635 ()
0018346-0002

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372628

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Central Server Software
In Commercial Distribution

  • 04260590372628 ()
0018440

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372611

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA 3D Workstation Software
In Commercial Distribution

  • 04260590372611 ()
0018438

  • Radiological video camera patient positioning/tracking system

LUNA 3D - 04260590372598

No Description
L A P GMBH LASER APPLIKATIONEN
LUNA Distribution Box
In Commercial Distribution

  • 04260590372598 ()
0018364-0009

  • Radiological video camera patient positioning/tracking system

Standard Imaging IMSure 3D QA Software - 00850019946604

Standard Imaging IMSure 3D software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91355
In Commercial Distribution

  • 00850019946604 ()
91355

  • Radiation therapy software

Standard Imaging IMSure 3D - 00850019946543

Standard Imaging IMSure 3D (IM3D) QA software is intended to be used for radiation dose calculation and radiation treatment plan quality assurance in radiation therapy.
STANDARD IMAGING INC.
91365
In Commercial Distribution

  • 00850019946543 ()
91365

  • Radiation therapy software

FilmQA Pro - 00850000065000

Radiation/Radiology Software
ASHLAND SPECIALTY INGREDIENTS G.P.
7.0
In Commercial Distribution

  • 00850000065000 ()
N/A

  • Radiation therapy software

PlanIQ - 05060608880874

Radiation therapy QA software.
SUN NUCLEAR CORP.
1216028
In Commercial Distribution

1216028

  • Radiation therapy software

SunCHECK - 05060608880348

SunCHECK is a software platform intended to collect, detect, compare, calculate, analyze, display, and store radiotherapy quality assurance and dosimetry data. SunCHECK is a server-based Web application which is accessible from any networked PC. It is intended to provide radiation therapy professionals with a platform that integrates patient QA, machine QA and data management workflows. This platform consists of a single GUI and database that is intended to provide a centralized view of a radiation therapy department’s QA efforts.
SUN NUCLEAR CORP.
1299028
In Commercial Distribution

  • 05060608880348 ()
1299000-0

  • Radiation therapy software

AlignRT Plus - 05056190500580

SimRT system, version 7.2
VISION RT LIMITED
SimRT 7.2 system
In Commercial Distribution

  • 05056190500580 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500566

No Description
VISION RT LIMITED
Lenovo P340 workstation
In Commercial Distribution

  • 05056190500566 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500559

No Description
VISION RT LIMITED
AlignRT InBore 6.4
In Commercial Distribution

  • 05056190500559 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500542

No Description
VISION RT LIMITED
InBore Power Repeater
In Commercial Distribution

  • 05056190500542 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500535

No Description
VISION RT LIMITED
InBore System Cabinet
In Commercial Distribution

  • 05056190500535 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500528

No Description
VISION RT LIMITED
InBore 60mm Calibration Plate Riser
In Commercial Distribution

  • 05056190500528 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500511

No Description
VISION RT LIMITED
InBore Patient Imaging Assembly
In Commercial Distribution

  • 05056190500511 ()


  • Radiological video camera patient positioning/tracking system

AlignRT Plus - 05056190500498

No Description
VISION RT LIMITED
Power Distribution Unit
In Commercial Distribution

  • 05056190500498 ()


  • Radiological video camera patient positioning/tracking system
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