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EVASOFT IMAGING SOFTWARE
ImageWorks
9992490800
In Commercial Distribution
- D83399924908000 ()
9992490800
- General-purpose dental x-ray system application software
MAXFRAME(TM) SOFTWARE
SYNTHES (U.S.A.) LP
03.312.000
In Commercial Distribution
- 07612334140258 ()
- H679033120000 ()
- 10886982260949 ()
03312000
- External orthopaedic fixation frame calculation software
Packaged OptiMAX Software
Ototronix, LLC
M6102
In Commercial Distribution
- M737M61021 ()
- Partially-implantable middle ear implant system
An application software program designed to function as a portal to allow software providers to make available radiological interpretive software [typically artificial intelligence (AI) based] for radiology professionals to access, use, evaluate, and compare. It is intended to facilitate distribution and hospital implementation of algorithms designed to assist image interpretation within a healthcare facility.
Terarecon Inc.
Eureka AI Interoperability Platform
In Commercial Distribution
- B220843002A8430031 ()
- Radiological image interpretive software sharing portal
Click2Correct/ Smart Correction software
Wishbone Medical, Inc.
C2C20210
In Commercial Distribution
- B562C2C20210 ()
- External orthopaedic fixation frame calculation software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553TEMPOSMART100 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution
- B553TEMPOINSIGHTS110 ()
- Home pharmaceutical management support software
Tempo Insights™ is the healthcare provider-facing component of TempoSmart. Neither Tempo Insights nor TempoSmart is intended to replace the research, expertise, judgment, or treatment provided to patients by healthcare providers.
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.0
Not in Commercial Distribution
- B553TEMPOINSIGHTS100 ()
- Home pharmaceutical management support software
TempoSmart™ is a Software as a Medical Device (SaMD) intended to be used by healthcare providers (HCPs) and their patients – aged 18 years and older - who have type 1 or type 2 diabetes. TempoSmart is intended to assist patients in managing their diabetes with guidance from their providers.
WELLDOC, INC.
v1.1
In Commercial Distribution
- B553TEMPOSMART110 ()
- Home pharmaceutical management support software
A cloud-based, PACS-server software application that gives dental organizations web access to patient images that have been captured from any DICOM-enabled device.
MASTERLINK LLC
1
In Commercial Distribution
- D875403051 ()
- General-purpose dental x-ray system application software