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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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Ceramill® - E4941791301

Dental Scanner.
Amann Girrbach AG
Map 200
In Commercial Distribution

  • E4941791301 ()
179130

  • Dental milling system, CAD/CAM, laboratory

Ceramill® - E4941795601

Dental scanner.
Amann Girrbach AG
Map600
In Commercial Distribution

  • E4941795601 ()
179560

  • Dental milling system, CAD/CAM, laboratory

Novux - E494179140NVX1

Dental Scanner.
Amann Girrbach AG
nx 100
Not in Commercial Distribution

  • E494179140NVX1 ()
179140-NVX

  • Dental milling system, CAD/CAM, laboratory

Ceramill® - E494179140NC1

Dental Scanner.
Amann Girrbach AG
Map400+
In Commercial Distribution

  • E494179140NC1 ()
179140NC

  • Dental milling system, CAD/CAM, laboratory

TomoTherapy Treatment Delivery System with iDMS - M65810682860

The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068286
In Commercial Distribution

  • M65810682860 ()
NA

  • Linear accelerator system

TomoTherapy Treatment Delivery System with iDMS - M65810682840

The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068284
In Commercial Distribution

  • M65810682840 ()
NA

  • Linear accelerator system

TomoTherapy Treatment Delivery System with iDMS - M65810682830

The TomoTherapy Treatment Delivery System with iDMS is indicated for the delivery of radiation therapy, stereotactic radiotherapy or stereotactic radiosurgery to tumors or other targeted tissues anywhere in the body under the direction of a licensed medical practitioner.
ACCURAY INCORPORATED
1068283
In Commercial Distribution

  • M65810682830 ()
NA

  • Linear accelerator system

iDMS™ Data Management System - M65810624090

Software, iDMS™ Data Management System, (Version 1.1.1.1) The iDMS™ Data Management System is indicated for the storage, retrieval, and processing of data utilized in the practice of radiotherapy, stereotactic radiotherapy and stereotactic radiosurgery.
ACCURAY INCORPORATED
1062409
In Commercial Distribution

  • M65810624090 ()
NA

  • Linear accelerator system

TomoTherapy Treatment Delivery System with iDMS - M65810620710

TomoTherapy Treatment Delivery System with iDMS, Version 1.1
ACCURAY INCORPORATED
1062071
In Commercial Distribution

  • M65810620710 ()
NA

  • Linear accelerator system

Radixact® Treatment Delivery System - M65810600000

The Radixact Treatment Delivery System is a radiation therapy delivery system that provides Image Guided Radiation Therapy (IGRT) using integral megavoltage CT imaging capabilities and delivers helical (rotational) and fixed-angle (non-rotational) radiation therapy to tumors and other targeted tissues. The Radixact Treatment Delivery System is a prescription device that delivers radiation in accordance with a physician approved plan. The Radixact Treatment Delivery System does not diagnose disease, recommend treatment regimens or quantify treatment effectiveness. It is not intended for diagnostic use.
ACCURAY INCORPORATED
1060000
In Commercial Distribution

  • M65810600000 ()
NA

  • Linear accelerator system
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