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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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NA - 08806086403467

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

RevoluX - 04719892352000

Hand Diagnostic Radiography Imaging System
NANORAY BIOTECH CO., LTD.
NDR705
In Commercial Distribution

  • 04719892352000 ()


  • Stationary basic diagnostic x-ray system, digital

Halifax Imaging Kit - 00628451892021

The Halifax Imaging Kit is part of the SR Suite product line, provides an alternative path to creating an SR Suite. The Halifax Imaging Kit is comprised of FDA cleared or certified X-Ray components integrated into an existing digital radiography room already containing an FDA cleared x-ray imaging system to form an SR Suite. The exposures of the Halifax Imaging Kit and the existing DR system are synchronized by replacing the trigger switches of the two systems with the Halifax Synchronization Switch. The Halifax Synchronization Switch ensures the two X-Ray imaging systems fire simultaneously, providing a pair of X-Ray images from two different perspectives to be taken at the exact same time. This process allows for Roentgen Stereophotogrammetric Analysis (RSA) or stereo orthopaedic radiography (SOR). RSA is a stereo x-ray technique that enables measurements more accurate and precise than single plane radiography based on phantom studies. The increased level of precision enables measurement of implant stability.
Halifax Biomedical Incorporated
1
In Commercial Distribution

  • 00628451892021 ()
P008943

  • Stationary basic diagnostic x-ray system, digital

DIGITAL RADIOGRAPHY SYSTEM - 04987670102196

DIGITAL RADIOGRAPHY SYSTEM
CANON MEDICAL SYSTEMS CORPORATION
DRAD-3000E
In Commercial Distribution

  • 04987670102196 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact - 04056869279985

No Description
Siemens Shanghai Medical Equipment Ltd.
11333888
In Commercial Distribution

  • 04056869279985 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact C - 04056869262147

No Description
Siemens Shanghai Medical Equipment Ltd.
11020896
In Commercial Distribution

  • 04056869262147 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion Max - 04056869050713

No Description
Siemens Shanghai Medical Equipment Ltd.
11020660
In Commercial Distribution

  • 04056869050713 ()


  • Stationary basic diagnostic x-ray system, digital

3D X-Ray Tube mount - 04056869025209

X-Ray Tube mount
Siemens Healthcare GmbH
10501776
In Commercial Distribution

  • 04056869025209 ()


  • Stationary basic diagnostic x-ray system, digital

Multix DR-Upgrade KIT VA20 - 04056869019925

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893540
In Commercial Distribution

  • 04056869019925 ()


  • Stationary basic diagnostic x-ray system, digital

Multix DR-Upgrade KIT VA20 - 04056869019918

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893697
In Commercial Distribution

  • 04056869019918 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion VA40 - 04056869019901

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10893300
In Commercial Distribution

  • 04056869019901 ()


  • Stationary basic diagnostic x-ray system, digital

Multix Fusion VA30 - 04056869019895

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10746667
In Commercial Distribution

  • 04056869019895 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact E - 04056869951386

No Description
Siemens Shanghai Medical Equipment Ltd.
11333999
In Commercial Distribution

  • 04056869951386 ()


  • Stationary basic diagnostic x-ray system, digital

YSIO X.pree - 04056869232904

No Description
Siemens Healthcare GmbH
11107464
In Commercial Distribution

  • 04056869232904 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX Impact - 04056869226545

No Description
Siemens Shanghai Medical Equipment Ltd.
11020788
In Commercial Distribution

  • 04056869226545 ()


  • Stationary basic diagnostic x-ray system, digital

MULTIX SELECT DR - 04056869006925

Radiography System
Siemens Shanghai Medical Equipment Ltd.
10569624
In Commercial Distribution

  • 04056869006925 ()


  • Stationary basic diagnostic x-ray system, digital

Ysio Max - 04056869004273

Radiography System
Siemens Healthcare GmbH
10762470
In Commercial Distribution

  • 04056869004273 ()


  • Stationary basic diagnostic x-ray system, digital

nfant® Thrive Feeding System - 00196852268917

No Description
NFANT LABS LLC
1
In Commercial Distribution

  • 00196852268917 ()
NTFS

  • Psychophysiological biofeedback system

NA - 00195278901880

Gemini Tube Stand
GE Hualun Medical Systems Co., Ltd
GCTS-C1
In Commercial Distribution

  • 00195278901880 ()


  • Stationary basic diagnostic x-ray system, digital

Optima - 00195278840233

XR646HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR646 HD Upgrade
In Commercial Distribution

  • 00195278840233 ()


  • Stationary basic diagnostic x-ray system, digital

Discovery - 00195278840226

XR656HD UDI Label
GE Hualun Medical Systems Co., Ltd
XR656 HD Upgrade
In Commercial Distribution

  • 00195278840226 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278832252

Galaxy 2.0 Wall Stand(Insert Left)
GE Hualun Medical Systems Co., Ltd
VMWS-2
In Commercial Distribution

  • 00195278832252 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278713766

Value Fixed Table
GE Hualun Medical Systems Co., Ltd
VFTBL-1
In Commercial Distribution

  • 00195278713766 ()
VFTBL-1

  • Stationary basic diagnostic x-ray system, digital

NA - 00195278713759

Galaxy 2.0 Wall Stand
GE Hualun Medical Systems Co., Ltd
VMWS-1
In Commercial Distribution

  • 00195278713759 ()
VMWS-1

  • Stationary basic diagnostic x-ray system, digital

NA - 00195278569745

BB X-RAY OVERHEAD TUBE SUSPENSION
GE Hualun Medical Systems Co., Ltd
5135678-10
In Commercial Distribution

  • 00195278569745 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278527455

Bamboo RAD Elevation Table
GE Hualun Medical Systems Co., Ltd
9999666
In Commercial Distribution

  • 00195278527455 ()
9999666

  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278526892

Definium Pace Select system designated medical device
GE Hualun Medical Systems Co., Ltd
Pace Select
In Commercial Distribution

  • 00195278526892 ()
B2604CAB

  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278118356

Definium Tempo System UDI
GE Hualun Medical Systems Co., Ltd
Tempo
In Commercial Distribution

  • 00195278118356 ()
B2401CAB

  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278070265

Definium Tempo Pro System UDI
GE Hualun Medical Systems Co., Ltd
Tempo Pro
In Commercial Distribution

  • 00195278070265 ()
B2402CAB

  • Stationary basic diagnostic x-ray system, digital

NA - 00195278012258

G4 Table HLA
GE Hualun Medical Systems Co., Ltd
6788888-3
In Commercial Distribution

  • 00195278012258 ()


  • Stationary basic diagnostic x-ray system, digital

Definium - 00195278913807

Definium Pace Select ET System UDI
GE Hualun Medical Systems Co., Ltd
Pace Select ET
In Commercial Distribution

  • 00195278913807 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278569813

BB X-RAY OVERHEAD TUBE SUSPENSION
GE Hualun Medical Systems Co., Ltd
5135678-9
In Commercial Distribution

  • 00195278569813 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00195278011022

G4 Non-Tilting Wallstand
GE Hualun Medical Systems Co., Ltd
5842636
Not in Commercial Distribution

  • 00195278011022 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953043301

Radiographic Table
GE Hualun Medical Systems Co., Ltd
GCTBL-C44
In Commercial Distribution

  • 00198953043301 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953043295

Gemini Tilting WS
GE Hualun Medical Systems Co., Ltd
GCEWS-C4
In Commercial Distribution

  • 00198953043295 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953043288

Gemini_Non-tilting_WS
GE Hualun Medical Systems Co., Ltd
GCWS-C6
In Commercial Distribution

  • 00198953043288 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953023266

G3A standard Wallstand
GE Hualun Medical Systems Co., Ltd
GCWS-C3
In Commercial Distribution

  • 00198953023266 ()


  • Stationary basic diagnostic x-ray system, digital

NA - 00198953023259

G4 Non-Tilting Wallstand
GE Hualun Medical Systems Co., Ltd
GCWS-C5
In Commercial Distribution

  • 00198953023259 ()


  • Stationary basic diagnostic x-ray system, digital

ArtPix Fixed Lite - 07290012104923

No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63648796
In Commercial Distribution

  • 07290012104923 ()


  • Stationary basic diagnostic x-ray system, digital

ArtPix Mobile Lite - 07290012104916

No Description
C.M.T. MEDICAL TECHNOLOGIES LTD.
63648095
In Commercial Distribution

  • 07290012104916 ()


  • Stationary basic diagnostic x-ray system, digital
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