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This visible ray curing light is a device to enhance a bleaching effect by exposing a visible ray to teeth with a bleaching agent is designed to be used in dental clinics.
This device emits 440 - 50nm blue visible ray by using 3 pieces of L.E.D (Light-Emitting Diode). It is a wireless type device and is convenient to move inside of the clinic.
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Aladdin features are:
- Easy to operate with touch switches to control the light intensity or operation time.
- Easy to carry or move. Once charged, the power code is not necessary to keep plugged in during operation.
- Removable parts like head, recharging unit, adapter, pole & foot.
- Adjustable light intensity. Left, Center & Right LEDs have 3 grades of light intensity (High, Normal & Low).
- Easy to store.
DXM CO., LTD
Aladdin
In Commercial Distribution
- 08800017900049 ()
- Tooth-bleaching acceleration unit
Remote Control Charging Cart "RCCS":
The Remote Control Charging Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Remote Control Charging Cart System can be used to hold and move medical equipment (i.e. the ImagingRing m / Loop-X Remote Control Panel) within the building or to position it in the room. It also provides a power supply to operate and charge the ImagingRing m / Loop-X Remote Control Panel.
The Remote Control Charging Cart is intended and released as accessory to the ImagingRing m (Loop-X). It is included in the technical documentation and 510(k) premarket submission of the ImagingRing m. Therefore it is registered under the same listing numbers and product code.
medPhoton GmbH
1
In Commercial Distribution
- 19120075320136 ()
A01052
- Electromechanical device/system transport trolley
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon Report Accelerator 1.4
In Commercial Distribution
- 00863670000349 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon iSite integrator 14.1
In Commercial Distribution
- 00863670000332 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon Server 2.2
In Commercial Distribution
- 00863670000325 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic
workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon LaunchPad 2.5
In Commercial Distribution
- 00863670000318 ()
- Radiological PACS software
imorgon Ultrasound PACS Solutions is a PACS system, comprised of acquisition components, a central system manager component, a diagnostic workstation component, and an archiving component. The data flow is such that patient and procedure information is optionally delivered to the central system manager, followed by the acquisition of the image objects directly from the image sources or by one of the acquisition components. When the central system manager registers the acquired image objects and the retrieved prior procedure data, a user can access the information by selecting the hem from the operator work list. The image data is transmitted to and rendered on the user's workstation using the diagnostic workstation components. imorgon Ultrasound PACS Solutions is also a teleradiology system used to receive DICOM images, scheduling information, organize and store them in an internal format, and to make that information available across a network via web and customized user interfaces. imorgon Ultrasound PACS Solutions is for hospitals, imaging centers, radiologist reading practices and any user who requires and is granted access to patient image, demographic and report
information.
IMORGON MEDICAL LLC
Imorgon View/Workstation 2.7
In Commercial Distribution
- 00863670000301 ()
- Radiological PACS software
Capture-R Ready-Screen (3) is used in the detection of unexpected IgG antibodies to red blood cells by manual, semi-automated or automated solid phase red blood cell adherence methods. This product contains three (3) test wells coated with red blood cell membranes from three (3) group O donors, as well as a positive control well, which all make up one (1) test of four (4) wells. Each strip consists of two antibody screens, i.e. two (2) sets of four (4) wells. Each microplate contains twelve (12) strips. Each microplate is packaged into a pouch. This particular product code package configuration is made up of five (5) microplates of the identical product, and the identical lot number, placed into the one (1) single box. The antigens Mia and Mur are represented with this product version.
IMMUCOR, INC.
0066816
In Commercial Distribution
- 10888234002369 ()
0066816
- Solid-phase red blood cell adherence antibody/antigen IVD
Mobile Monitor Cart System "MMCS":
The Mobile Monitor Cart System (including the components mounted on it) is intended for use in healthcare facilities in general and near patients in operating theatres. The Mobile Monitor Cart System can be used to move medical equipment (e.g. the IRm control unit) within the building or to position it in the room.
If the system is used in conjunction with the IRm operating unit, the mobile monitor cart system expands the display and control options of the mobile X-ray imaging system "ImagingRing m" or "Loop-X®" (abbreviated Rm) of medPhoton GmbH.
The mobile monitor cart system is listed and released as an accessory and included in the technical documentation and 510(k) premarket submissions for the ImagingRing m. Therefore it is also registered under the same listing number and product code.
medPhoton GmbH
1
In Commercial Distribution
- 19120075320105 ()
A0093
- Image display unit, colour
The sterile "Procedural Packages for Diagnosis and Surgery" are intended for use by specialized personnel and are composed of consumables and devices intended for the preparation of the operating field, maintenance of cleanliness (ensuring the hygiene of the field and limiting the risk of contamination) and the performance of various types of surgery.
The devices provided can be:
- non-invasive devices, for the preparation of the operating field - for example: drapes, gowns, masks and accessories (bandages, sheaths, tool pockets, bags for collecting liquids, fixed pliers for drapes, etc.)
- invasive surgical devices for temporary use not in contact with the central circulatory system and with the nervous system - for example: needles and syringes with needle, disposable scalpels and gauze.
- devices for channeling liquids intended for irrigation.
Possible combination of any of the devices mentioned are identified with different UDI code listed in the section "Package DI" Model number : X = alphabetic character YYYY=n° of 4 number character.
OMNIA SRL
12.XYYYY.00
In Commercial Distribution
- 08056646500840 ()
- General surgical procedure kit, non-medicated, single-use