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VitreaView is a medical image viewing and information distribution application that provides access, through the internet and within the enterprise to multi-modality softcopy medical images, reports, and other patient-related information. This data is hosted within disparate archives and repositories for diagnosis, review, communication, and reporting of DICOM and non-DICOM data.
Display monitors used for reading medical images for diagnostic purposes must comply with the applicable regulatory approvals and quality control requirements for their use and maintenance.
Lossy compressed mammography images and digitized film screen images must not be reviewed for primary image interpretations.
When accessing VitreaView from a mobile device, images viewed are for informational purposes only and not intended for diagnostic use.
Canon Medical Informatics, Inc.
7.0.1
In Commercial Distribution
- 00853866003261 ()
- Radiological PACS software
The DIO SM Implant System is comprised of dental implant, Superstructure, Instruments for prosthetics and Surgical Instruments
The DIO SM Implant System is specially designed for use in dental implant surgery. A successfully osseointegrated implant will achieve a firm implant when surgically implanted under controlled conditions, per well known clinical studies. There are intended for use in partialhttps://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=536963#ly or fully edentulous mandibles and maxillae, in support of single or multiple-unit restorations.
The superstructures consist or screws(Closing Screw, Coping Screw), abutments (Screw retained type, Cemented retainde type, Overdenture retainde type), Solid protect cap.
The screws are made of commercial pure titanium, grade 4(ASTM F76) and Ti-6A1-4VELI(ASTM F136) intended to be usedin a narrow tooth gap after implant insertion and to protect exposed top of commercial pure titanium, grade 3 and grade 4(ASTM F76), Ti-6A1-4VELI(ASTM F136), white gold alloy, POM, PMMA. The intentions of each abutment are described in part 2.4. The protect cap is made of POM and intended to protect infecting other substances after solid abutment is fixed on the implant.
DIO Corporation
SAC 5824T(II)
Not in Commercial Distribution
- 08806195923108 ()
- Ø5.8X4.0(2.0)mm
SAC 5824T(II)
- Screw endosteal dental implant, two-piece
Move into multi-message communication with the BIG Step-by-Step speech device. Activate the large colored top to play the first message. When done, activate the top again to play another message. New sequences of messages are easily and quickly recorded to the BIG Step-by-Step on the fly, or use the levels pre-record up to three sets of messages ahead of time.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Record pages of a book to tell a story
Count from 1 to 10
Ask a series of questions
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the BIG Step-by-Step. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000043
In Commercial Distribution
- 00850011150085 ()
10000043
- Assistive speech generator
Start your communication journey with a LITTLEmack speech device. With a press of the colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the LITTLEmack on the fly throughout the day to provide opportunities to communicate in almost any scenario.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Request like "I want" or "I need help"
Participate in an activity with "turn the page" or "It's your turn"
Tell your classmates what you did over the weekend during a morning meeting
Add communication to a switch controlled toy or applianceg
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the LITTLEmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000042
In Commercial Distribution
- 00850011150078 ()
10000042
- Assistive speech generator
Start your communication journey with a BIGmack speech device. With a press of the large colored top, an individual can communicate a single message up to 2-minutes long. New messages are easily and quickly recorded to the BIGmack on the fly throughout the day to provide opportunities to communicate in almost any scenario.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Request like "I want" or "I need help"
Participate in an activity with "turn the page" or "It's your turn"
Tell your classmates what you did over the weekend during a morning meeting
Add communication to a switch controlled toy or applianceg
Features
Better than ever digital sound output suitable for almost any environment
Includes red, yellow, green, and blue colored tops
Clear snap cover to attach picture symbols and provide communication context to the user
Soft-touch coating makes the device easier to hold
Symbol Overlays
Symbol overlays are not included with the BIGmack. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000041
In Commercial Distribution
- 00850011150061 ()
10000041
- Uncarboxylated matrix Gla protein (ucMGP) IVD, kit, chemiluminescent immunoassay
Clue Birth Control is a feature of the Clue period tracker mobile application. Clue Birth Control’s proprietary algorithm uses period start date information entered by the user to provide predictions of “high risk days” and “low risk days” for becoming pregnant based on a Fertility Awareness Based Method (FABM) of contraception. Identification of high risk days allows the user to determine the days on which her risk of conception is highest, and then make choices about either abstaining from sex or using a barrier method of contraception to prevent pregnancy. To use Clue Birth Control, users go through an onboarding process from within the Clue app, during which they are asked to provide information that will determine whether they meet the Clue Birth Control use criteria. Clue Birth Control can only be used by women who are between 18 and 45 years old and their last 12 cycles were between 20 and 40 days and the difference between the lengths of the shortest and longest cycles is less than or equal to 9 days. In addition, users must have had at least three cycles (four periods) after stopping hormonal birth control (HBC) or since the end of a pregnancy.
BioWink GmbH
1
In Commercial Distribution
- 04260749840008 ()
- Self-care monitoring/reporting software
Fantastic-M orthodontic adhesive is designed to set on contact, “Cure-On Touch”, thus saving the dentist chair time. This procedure can also minimize erratic mixing procedures, and therefore https://gudid.fda.gov/gudid/app/admin/udi/recordDetails.xhtml?pageType=manageDI&pageDataLoaded=false&pageMode=read+only&deviceRecordKey=930708#reducing the possibility of errors caused by paste inconsistencies, a problem often encountered in other types of adhesives. Fantastic M has strong, reliable bond, mistake-proof cure-on-touch system: fast and easy to use, color stable and it economical in application. Fantastic-M starts to set only after the bracket is applied to the tooth, giving the operator the convenience and security of virtually unlimited working time. This material is very reliable due to its outstanding adhesive properties. Also, due to the soft filler, Fantastic-M is easy to clean. The material is highly tacky, therefore, brackets will not slide after being placed on the tooth, but rather they will remain immobilized until the material cures. Delayed cure time permits the operator to correct the position of the brackets up to 15 seconds after placement. Fantastic-M is very economical, unlike conventional adhesives that are normally mixed in excess.
DENT ZAR, INC.
0055
In Commercial Distribution
- D83600550 ()
0055
- Orthodontic bracket adhesive
The SuperTalker FeatherTouch speech device provides an opportunity for users of all abilities to communicate. Change out the message grids to create a unique speech device with one, two, four, or eight messages. The FeatherTouch membrane responds to the lightest touches and smallest fingers, and makes it easy for almost anyone to communicate with one message or eight different messages.
Includes ableCARE on-demand support
Built ableSTRONG to endure drops and other environmental conditions
Made from ableSAFE materials and tested by third-party safety labs
Common Uses
Record messages like "turn the page", "look", "I like this", and "I want to stop" for use when reading a book
Record a single message to make a request like "I want" or "I need help"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Interchangeable message grids for one, two, four, or eight messages that support picture symbol overlays
Symbol Overlays
Symbol overlays are not included with the SuperTalker FeatherTouch. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000031
In Commercial Distribution
- 00186648000548 ()
10000031
- Assistive speech generator
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection. The device results should not be used alone to make any diagnosis and/or treatment decisions.
Curemetrix, Inc.
V1.6
In Commercial Distribution
- 00860006442699 ()
- Radiology DICOM image processing application software
cmAngio is intended to process screening mammograms to aid a qualified interpreting physician in the current manual process of identifying Breast Arterial Calcification (BAC).
cmAngio, a proprietary artificial intelligence (AI) based software, is intended to detect, at the study and breast level, the presence or absence of Breast Arterial Calcifications (BAC), an incidental finding in both Full Field Digital Mammogram (FFDM) and Digital Breast Tomosynthesis (DBT) screening mammograms. The device also marks BAC segments on thumbnails of images for localization of BAC.
The software is intended to be used by qualified interpreting physicians in parallel with breast screening mammography workflow. The device is not intended for primary interpretation of digital mammography images as used for breast cancer detection and should not be used alone to make any diagnosis and/or treatment decisions.
cmAngio is for prescription use only.
Curemetrix, Inc.
V1.0
In Commercial Distribution
- 00860006442682 ()
- Radiology DICOM image processing application software