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The âTyto Insights for Wheeze Detectionâ is an over-the-counter artificial intelligence (AI) enabled decision support
software system used in the evaluation of lung sounds in adults and pediatrics. It automatically analyses the acoustic
signal of the lung as recorded by the FDA cleared compatible Tyto Stethoscope and identifies recordings where a specific
abnormal lung sound suggestive of âWheezeâ is suspected. It is not intended to detect other abnormal or normal lung
sounds. A licensed health care professionalâs advice is required to understand the meaning of the Tyto Insights for
Wheeze Detection result. Healthcare providers should consider the device result in conjunction with recording and other
relevant patient data.
TYTO CARE LTD
Tyto Insights for Wheeze Detection _US
In Commercial Distribution
- 07290016672886 ()
- Electronic acoustic stethoscope
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device.
Note: MMLâs customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customerâs collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customerâs specific collection kit.
Mml Diagnostics Packaging, Inc.
CD215
In Commercial Distribution
- 00862255000347 ()
CD215
- General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device.
Note: MMLâs customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customerâs collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customerâs specific collection kit.
Mml Diagnostics Packaging, Inc.
CD650
In Commercial Distribution
- 00862255000330 ()
CD650
- General-purpose absorbent tip applicator/swab, single-use
The MML Specimen Collection Swab is an absorbent polyester-tipped applicator intended for medical purposes that consists of an absorbent polyester swab bud adhered to a plastic shaft. The single use device is intended to collect a specimen from a patient. The MML Specimen Collection Swab is a Class 1 sterile device.
Note: MMLâs customers purchase this swab to be a component of their specimen collection/testing kits, as specified by the customer. This swab is only distributed as a component of a customerâs collection/testing kit and is not sold or distributed as a stand-alone device. The MML Specimen Collection Swab is intended to be used for the collection of a broad spectrum of specimens including human clinical specimens, as defined by the customerâs specific collection kit.
Mml Diagnostics Packaging, Inc.
CD651
In Commercial Distribution
- 00862255000323 ()
CD651
- General-purpose absorbent tip applicator/swab, single-use
Merge PACS⢠is a standards-based medical imaging diagnostic workstation that serves as an adjunct to assist the clinician to view, read, and report their findings. Merge PACS processes and displays medical images from DICOM-compliant modalities. The device is designed to enable efficient workflows by maintaining cliniciansâ worklists and retrieving and managing studies for reading, reporting, communication, and storage.
Merge PACS software runs on off-the-shelf computer hardware and can be configured to operate standalone or to integrate with vendor-neutral imaging archives (VNAs) such as iConnect Enterprise Archive (iCEA) for image storage, and with radiological and hospital information systems (RIS and HIS) and medical record systems (EMR, EHR, etc.).
MERGE HEALTHCARE SOLUTIONS INC.
7.3
In Commercial Distribution
- 00842000100690 ()
- Radiology picture archiving and communication system workstation
IntelliSpace Cardiovascular is a comprehensive cardiac image and information management solution designed to provide clinicians with convenient access to the detailed records of all cardiac patients across their complete cardiovascular care continuum. The application also provides hospital administrators and department managers with detailed operational information, as well as productivity and outcomes reporting. Key components include a wide range of detailed clinical modules that capture data during diagnostic/therapeutic procedures and patient followâup encounters. Interfaces to other systems and devices within the cardiology departments as well as across the enterprise system, such as HIS/EMR, are available. The solution supports a remote deployment model.
Philips Medical Systems Nederland B.V.
8
In Commercial Distribution
- 00884838122000 ()
830089
- Radiology picture archiving and communication system workstation
The Tyto Insights for Crackles Detection is an over-the-counter artificial intelligence (AI)
enabled decision support software system used in the evaluation of lung sounds in adults
and pediatrics (2 years and older). It automatically analyzes the acoustic signal of the lung
as recorded by the FDA 510k cleared compatible Tyto Stethoscope and identifies recordings
where a specific abnormal lung sound suggestive of âCrackleâ is suspected. It is not intended
to detect other abnormal or normal lung sounds. A licensed health care professionalâs advice
is required to understand the meaning of the Tyto Insights for Crackles Detection result.
Healthcare providers should consider the device result in conjunction with recording and
other relevant patient data.
TYTO CARE LTD
Tyto Insights for Crackles Detection
In Commercial Distribution
- 07290020123008 ()
- Electronic acoustic stethoscope
The easiest way to provide an individual with two side-by-side communication choices is with the iTalk2 speech device. Activate the red or yellow top to play the desired message. New messages are easily and quickly recorded to the iTalk2 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
Use for yes and no responses
Choose between two options of food, drink, or activities
Provide a way to make two unique requests like "I need help" and "I'm done"
Features
Better than ever digital sound output suitable for almost any environment
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 iTalk2. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000045
In Commercial Distribution
- 00850011150108 ()
10000045
- Assistive speech generator
The easiest way to provide an individual with four side-by-side communication choices is with the iTalk4 speech device. Activate the colored top to play the desired message. New messages are easily and quickly recorded to the iTalk4 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
Provide a unique response to a question like "What is the weather like outside?"
Respond to an assessment
Provide a way to make unique requests like "I need help", "I'm done", "I need to use the bathroom", and "I'm thirsty"
Add communication to a switch controlled toy or appliance
Features
Better than ever digital sound output suitable for almost any environment
Clear snap cover to attach picture symbols and provide communication context to the user
Symbol Overlays
Symbol overlays are not included with the iTalk4. Download the free AbleNet Symbol Overlay app for iPad to create symbol overlays for your AbleNet speech device.
Ablenet, Inc.
10000028
In Commercial Distribution
- 00186648000531 ()
10000028
- Assistive speech generator
Vitrea View 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.
7.1
In Commercial Distribution
- 00853866003285 ()
- Radiological PACS software