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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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DR-ID 602SE - 04547410256925

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A W E
In Commercial Distribution

  • 04547410256925 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 601SE - 04547410256871

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A W E
In Commercial Distribution

  • 04547410256871 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 601SE - 04547410256840

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A W E
In Commercial Distribution

  • 04547410256840 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 611SE - 04547410256475

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE W E
In Commercial Distribution

  • 04547410256475 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C43s - 04547410245059

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE WIRED E
In Commercial Distribution

  • 04547410245059 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C43i - 04547410245042

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 612 SE E
In Commercial Distribution

  • 04547410245042 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G43s - 04547410235975

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE WIRED A E
In Commercial Distribution

  • 04547410235975 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G43i - 04547410235968

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 602 SE A E
In Commercial Distribution

  • 04547410235968 ()

  • 460x460x15.4mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35s - 04547410235951

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE WIRED A E
In Commercial Distribution

  • 04547410235951 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO G35i - 04547410235944

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 601 SE A E
In Commercial Distribution

  • 04547410235944 ()

  • 460x384x14.8mm


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410235937

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 601 MC-WITHOUT SOFT E
In Commercial Distribution

  • 04547410235937 ()


  • Stationary basic diagnostic x-ray system, digital

Cradle - 04547410235920

The Cradle for 24 is used for storing the flat panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle for 24 can be charged. In addition, when the Cradle for 24 is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR613 STAND E
In Commercial Distribution

  • 04547410235920 ()


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24s - 04547410225587

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE WIRED E
In Commercial Distribution

  • 04547410225587 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C24i - 04547410225570

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 613 SE E
In Commercial Distribution

  • 04547410225570 ()

  • 328x268x15.7mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C35s - 04547410196870

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE WIRED E
In Commercial Distribution

  • 04547410196870 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

FDR D-EVO plus C35i - 04547410196863

The DR-ID 600SE, DR-ID 601SE and DR-ID 602SE incorporate a GOS indirect panel. The DR-ID 611SE, DR-ID 612SE and DR-ID 613SE incorporate a CsI indirect panel. There are six types of flat panel sensors: DR-ID 601SE, DR-ID 602SE, DR-ID 611SE, DR-ID 612SE and DR-ID 613SE (wireless/wired communication mode) and DR-ID 600SE (wired communication mode).
FUJIFILM CORPORATION
DR-ID 611 SE E
In Commercial Distribution

  • 04547410196863 ()

  • 460x384x15.5mm


  • Stationary basic diagnostic x-ray system, digital

SE storage case - 04547410193565

Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR602 SE CASE E
In Commercial Distribution

  • 04547410193565 ()


  • Stationary basic diagnostic x-ray system, digital

Cradle - 04547410180282

The Cradle is used for storing the fl at panel sensor in a standing position. By using in combination with the CALNEO C power supply unit or the AC adapter for cradle (optional), the battery pack for the fl at panel sensor inserted into the Cradle can be charged. In addition, when the Cradle is connected to the CALNEO C power supply unit, the wireless communication setting can be switched.
FUJIFILM CORPORATION
DR600 STAND E
In Commercial Distribution

  • 04547410180282 ()


  • Stationary basic diagnostic x-ray system, digital

Li-ion Battery charger - 04547410180220

A battery charger for the battery pack. Three packs can be charged at the same time.
FUJIFILM CORPORATION
DR601 SE BATTERY CHARGER E
In Commercial Distribution

  • 04547410180220 ()


  • Stationary basic diagnostic x-ray system, digital

Li-ion Battery - 04547410180213

A battery pack for the flat panel sensor (DR-ID 601SE, DR-ID 602SE and DR-ID 611SE) used in wireless communication mode.
FUJIFILM CORPORATION
DR601 SE BATTERY E
In Commercial Distribution

  • 04547410180213 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MP - 04547410178678

Supplies the power to the flat panel sensor and connects the flat panel sensor and the control cabinet.
FUJIFILM CORPORATION
DR-ID 600/601 MP E
In Commercial Distribution

  • 04547410178678 ()


  • Stationary basic diagnostic x-ray system, digital

SE storage case - 04547410134667

Storage case for Flat Panel Senser
FUJIFILM CORPORATION
DR600 SE CASE E
In Commercial Distribution

  • 04547410134667 ()


  • Stationary basic diagnostic x-ray system, digital

DR-ID 600MC - 04547410134551

A personal computer used for controlling the flat panel sensor and performing image processing.
FUJIFILM CORPORATION
DR-ID 600 MC E
In Commercial Distribution

  • 04547410134551 ()


  • Stationary basic diagnostic x-ray system, digital

Neuroband - 00850010086033

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30SB
Not in Commercial Distribution

  • 00850010086033 ()


  • Psychophysiological biofeedback system

Neuroband - 00850010086026

Neuroband is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep, and a mobile application. Neuroband is intended to generate reports to provide information about sleep, in-home, or clinical trial settings.
DREEM
GFM30MD
Not in Commercial Distribution

  • 00850010086026 ()


  • Psychophysiological biofeedback system

Dreem 2 - 00850010086019

Dreem 2 is a wireless sleep monitoring system consisting of a wearable headband that contains sensors to monitor sleep and a mobile application. Dreem 2 is intended to aid in relaxing and falling asleep and to generate reports, advices and contents to help the user better understand his or her sleep, and take steps to improve it.
DREEM
EFM00MD
Not in Commercial Distribution

  • 00850010086019 ()


  • Psychophysiological biofeedback system

PodSKAN HF Diagnostic X-ray System - 08904269415105

PodSKAN is an advanced high frequency type X-Ray system designed for superior image quality with powerful 2.8KW generator and very low leakage radiation. The system houses two microprocessors, one for control/supervisory functions and another one man-machine/User interface. It can be easily plugged into 16A Wall socket with 120 VAC or 240 VAC, 50/60 Hz.. The technology incorporates feedback circuits to ensure highest accuracy & reproducibility of X-Ray output.
SKANRAY TECHNOLOGIES LIMITED
303-002665-0
In Commercial Distribution

  • 08904269415105 ()


  • Stationary basic diagnostic x-ray system, digital

SKANRAD 400 - 08904269409531

Skanrad 400 is an advanced high frequency type X-ray system designed for superior image quality for radiographic use with powerful 32 kW generator and very low X-ray leakage radiation
SKANRAY TECHNOLOGIES LIMITED
303-000783-4
In Commercial Distribution

  • 08904269409531 ()


  • 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

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

Axon - 09413000107500

Axon Neurofeedback software Application for iOS
EXSURGO LIMITED
iOS
In Commercial Distribution

  • 09413000107500 ()
100318

  • Psychophysiological biofeedback system

Axon 2 - 09413000095982

EEG-based Neurofeedback Headset for use with the Axon mobile App, enabling users to modulate and redirect brain activity towards frequencies associated with relaxation and calm focused attention.
EXSURGO LIMITED
100500
In Commercial Distribution

  • 09413000095982 ()
100500

  • Psychophysiological biofeedback system

Axon - 09413000078510

Neurofeedback Software Application for Android
EXSURGO LIMITED
Android
In Commercial Distribution

  • 09413000078510 ()
100321

  • Psychophysiological biofeedback system

Axon - 09413000078459

EEG Biofeedback (Neurofeedback) Kit - Large includes Axon EEG headset - Large, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078459 ()
100161

  • Psychophysiological biofeedback system

Axon - 09413000078442

Neurofeedback Kit - Medium includes Axon EEG headset - Medium, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000078442 ()
100160

  • Psychophysiological biofeedback system

Axon - 09413000078435

Neurofeedback Kit - Small includes Axon EEG headset - Small, Tablet with Axon Neurofeedback Software Application
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078435 ()
100140

  • Psychophysiological biofeedback system

Axon - 09413000078428

EEG Headset - Large
EXSURGO LIMITED
Large
Not in Commercial Distribution

  • 09413000078428 ()
100143

  • Psychophysiological biofeedback system

Axon - 09413000078411

EEG Headset - Small
EXSURGO LIMITED
Small
Not in Commercial Distribution

  • 09413000078411 ()
100141

  • Psychophysiological biofeedback system

Axon - 09413000077094

EEG Headset - Medium
EXSURGO LIMITED
Medium
Not in Commercial Distribution

  • 09413000077094 ()
100142

  • Psychophysiological biofeedback system

Yushan - 04719879300062

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14C
In Commercial Distribution

  • 04719879300062 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300055

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ge
In Commercial Distribution

  • 04719879300055 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300048

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17G
In Commercial Distribution

  • 04719879300048 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300031

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17C
In Commercial Distribution

  • 04719879300031 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300024

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14G
In Commercial Distribution

  • 04719879300024 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300017

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V14C
In Commercial Distribution

  • 04719879300017 ()


  • 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

Yushan - 04719879300086

No Description
INNOCARE OPTOELECTRONICS CORPORATION
V17Ce
In Commercial Distribution

  • 04719879300086 ()


  • Stationary basic diagnostic x-ray system, digital

Yushan - 04719879300079

No Description
INNOCARE OPTOELECTRONICS CORPORATION
F14G
In Commercial Distribution

  • 04719879300079 ()


  • Stationary basic diagnostic x-ray system, digital

PARO Robot - 04580537541246

A baby seal type robot with artificial intelligence in light Pink Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Pink
In Commercial Distribution

  • 04580537541246 ()
V9-14UC

  • Psychophysiological biofeedback system

PARO Robot - 04580537541239

A baby seal type robot with artificial intelligence in Charcoal Gray Color. Neurological Therapeutic Medical Device in Biofeedback Medical Device. For psycho-physiological biofeedback for pain, anxiety, depression, sleep and behavioral issues such as aggression, agitation and wandering, and for rehabilitation of speech, swallowing and fine motor skills. For patients of dementia, cancer, PTSD, brain injury, Parkinson's disease, etc
INTELLIGENT SYSTEM CO.,LTD.
MCR-900 UC Charcoal Gray
In Commercial Distribution

  • 04580537541239 ()
V9-14UC

  • Psychophysiological biofeedback system
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