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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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The GM60A-40S Digital Mobile X-ray Imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GM60A-40S
In Commercial Distribution

  • 08806088088266 ()


  • Mobile basic diagnostic x-ray system, digital
The GC80 Series Digital X-ray imaging System is intended for use in generating radiographic images of human anatomy by a qualified/trained doctor or technician. This device is not intended for mammographic applications.
Samsung Electronics Co., Ltd.
GC80
In Commercial Distribution

  • 08806086403467 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
GE MEDICAL SYSTEMS, INC.
XR240amx HD Upgrade Gen2
In Commercial Distribution

  • 00840682145749 ()


  • Mobile basic diagnostic x-ray system, digital
Optima XR646 HD System
GE Hualun Medical Systems Co., Ltd
XR646 HD
In Commercial Distribution

  • 00840682142175 ()


  • Stationary basic diagnostic x-ray system, digital
XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00840682142168 ()


  • Stationary basic diagnostic x-ray system, digital
No Description
THALES AVS FRANCE SAS
62833765
In Commercial Distribution

  • 03701440100172 ()


  • Stationary basic diagnostic x-ray system, digital
The TruSight Oncology Comprehensive assay is an enrichment-based targeted next generation sequencing (NGS) in-vitro diagnostic test comprised of library preparation and enrichment reagents to enable DNA and/or RNA sequencing from Formalin-Fixed, Paraffin-Embedded (FFPE) tissue from solid tumors encompassing multiple cancer types.
ILLUMINA, INC.
20032573
In Commercial Distribution

  • 00816270020217 ()


  • Cancer-related multiple gene mutation/mRNA expression IVD, kit, nucleic acid technique (NAT)
X-Ray System, Podiatry DR Ready (70kVp,10mA).
KONICA MINOLTA MEDICAL IMAGING U.S.A., INC.
XR410i
In Commercial Distribution

  • 00817100020148 ()
PXS-710

  • Stationary basic diagnostic x-ray system, digital
No Description
NANO-X IMAGING LTD
2.2.
In Commercial Distribution

  • 07290018465004 ()


  • Multi-directional tomography x-ray system
Stationary x-ray system intended for obtaining radiographic images of various portions of the human body in a clinical environment. The device is not intended for mammography.
Arcoma AB
0180
In Commercial Distribution

  • 07350008750050 ()


  • Stationary basic diagnostic x-ray system, digital
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