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No Description
PathAI, Inc.
11124001
In Commercial Distribution
- 00860006696221 ()
- Histology/cytology/microbiology image-analysis interpretive software IVD
REMI Vigilenz AI for Event Detection
Epitel, Inc.
1.x.x
In Commercial Distribution
- 00860005388189 ()
20104
- Bioelectrical signal analysis software
FullFocus is a web-based software-only device for viewing and manipulating digital pathology images of glass slides obtained from the Philips IntelliSite Pathology Solution (PIPS) Ultra Fast Scanner (UFS) on the monitor displays that are validated with verified test methods to meet required performance characteristics. FullFocus renders the uploaded slide images and is an aid to the pathologist to review, interpret and manage digital images of pathology slides for primary diagnosis.
PAIGE.AI, INC.
2.X
In Commercial Distribution
- 00860007599101 ()
- Pathology information system
No Description
Anumana, Inc.
v 2.3.0 (1010)
- Cardiopulmonary physiological parameter analysis software
The Low Ejection Fraction AI-ECG Algorithm interprets 12-lead ECG voltage times series data using an artificial intelligence-based algorithm. The device analyzes 10 seconds of a single 12-lead ECG acquisition, and within seconds provides a prediction of likelihood of LVEF (ejection fraction less than or equal to 40%) to third party software. The results are displayed by the thirdparty software on a device such as a smartphone, tablet, or PC. The Low Ejection Fraction AIECG Algorithm was trained to predict Low LVEF using positive and control cohorts, and the prediction of Low LVEF in patients is generated using defined conditions and covariates.
The Low Ejection Fraction AI-ECG Algorithm device is intended to address the unmet need for a point-of-care screen for LVEF less than or equal to 40% and is expected to be used by cardiologists, front-line clinicians at primary care, urgent care, and emergency care settings, where cardiac imaging may not be available or may be difficult or unreliable for clinicians to operate. Clinicians will use the Low Ejection Fraction AI-ECG Algorithm to aid in screening for LVEF less than or equal to 40% and making a decision for further cardiac evaluation.
Anumana, Inc.
v.2.2.0 (1010)
In Commercial Distribution
- 00860007426407 ()
- Cardiopulmonary physiological parameter analysis software
CaloPix is a software only device for viewing and management of digital images of scanned surgical pathology slides prepared from Formalin-Fixed Paraffin Embedded (FFPE) tissue. CaloPix is intended for in vitro diagnostic use as an aid to the pathologist to review, interpret and manage these digital slide images for the purpose of primary diagnosis. CaloPix is not intended for use with frozen sections, cytology, or non-FFPE hematopathology specimens.
CaloPix is intended in viewing, interpreting and managing digital Whole Slide Images (WSI) of glass slides obtained from the Hamamatsu NanoZoomer S360MD slide scanner (NDPI file format) and viewed on the JVC Kenwood JD-C240BN01A display, as well as those obtained from the Leica Aperio GT 450 DX scanner (SVS file format) and viewed in the Dell U3223QE display.
TRIBUN HEALTH
6.1.0 IVDUS
In Commercial Distribution
- 03760408001005 ()
- Pathology information system
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
3.X
Not in Commercial Distribution
- B553202257OTC0 ()
- Self-care monitoring/reporting software
The Welldoc® App for Diabetes in Pregnancy and Insulin Pump Users (the software) is Software as a Medical Device (SaMD) intended to be used by patients – aged 18 years and older – who have type 1, type 2 diabetes, or gestational diabetes - who are also pregnant or use an insulin pump.
The software is intended to help people with diabetes manage their health in their daily environment. The software, running on a mobile phone, collects health data, promotes healthy behavior, and encourages adherence to treatment plans and self-monitoring practices as advised by a healthcare provider. The software also generates
electronic reports intended for a healthcare provider.
The software provides secure transfer, storage, and secondary display of data from devices such as continuous glucose monitors (CGM), blood glucose meters, blood pressure monitors, activity trackers, and weight scales as well as self-reported health information. When receiving CGM data, the software also serves as a secondary CGM alarm system, providing alerts to enable immediate awareness of conditions that may require clinical intervention. The software also performs retrospective analysis of CGM data which may be used by people with diabetes and their healthcare provider when determining therapeutic strategies.
The software provides educational content to encourage behaviors which may help living well with diabetes based on guidance from healthcare professional organizations. This may include promoting healthy lifestyle choices such as getting enough sleep, eating a balanced diet, maintaining a healthy weight, and promoting physical activity.
The software is not intended to replace the care provided by a licensed healthcare professional, including prescriptions, diagnosis, or treatment nor is it intended to replace self-monitoring practices as advised by a physician. The software does not provide treatment recommendations.
WELLDOC, INC.
v2.X
Not in Commercial Distribution
- B553202057OTC0 ()
- Self-care monitoring/reporting software
The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5905-01-300
In Commercial Distribution
- 00817491023513 ()
FG-5905-01-300
- Implantable glucose monitoring system
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5705-01-300
In Commercial Distribution
- 00817491023506 ()
FG-5705-01-300
- Implantable glucose monitoring system
The Eversense DMS Pro is a software intended for clinic use. Eversense DMS Pro can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5900-01-300
Not in Commercial Distribution
- 00817491021885 ()
FG-5900-01-300
- Implantable glucose monitoring system
Eversense DMS is a software intended for home use. Eversense DMS can be used to review and evaluate historical glucose data from compatible devices and systems.
SENSEONICS, INCORPORATED
FG-5700-01-300
Not in Commercial Distribution
- 00817491021878 ()
FG-5700-01-300
- Implantable glucose monitoring system
Data management reporting software use for Dexcom Continuous Glucose Monitoring devices.
SWEETSPOT DIABETES CARE, INC.
350-0010
Not in Commercial Distribution
- B059POW3500010 ()
350-0010
- Noninvasive interstitial fluid glucose monitoring device
Dexcom CLARITY software, web-based data management product is intended
for use by both patients and healthcare professionals to assist people with diabetes in the
review, analysis and evaluation of historical CGM data to support effective diabetes
management. It is intended for use as an accessory to CGM devices with data interface
capabilities.
With RCP, it provides additional administrative features for use by Clinicians to
access Dexcom CLARITY reports (digital or print) for their patients with diabetes. These
features do not change the intended use of CLARITY. They improve the usefulness of it from
the clinician perspective.
SWEETSPOT DIABETES CARE, INC.
350-0011
Not in Commercial Distribution
- B059CLARITY35000011 ()
350-0011
- Noninvasive interstitial fluid glucose monitoring device
No Description
Vysioneer Inc.
2.1.2
In Commercial Distribution
- 04719884900011 ()
- Radiology DICOM image processing application software
Electrode junction box (256 channel)
NIHON KOHDEN CORPORATION
JE-120A-24
In Commercial Distribution
- 04931921108734 ()
JE-120A-24
- Electroencephalograph
Electrode junction box (192 channel)
NIHON KOHDEN CORPORATION
JE-120A-23
In Commercial Distribution
- 04931921108727 ()
JE-120A-23
- Electroencephalograph
Electrode junction box (128 channel)
NIHON KOHDEN CORPORATION
JE-120A-22
In Commercial Distribution
- 04931921108710 ()
JE-120A-22
- Electroencephalograph
Electrode junction box (64 channel)
NIHON KOHDEN CORPORATION
JE-120A
In Commercial Distribution
- 04931921108703 ()
JE-120A-21
- Electroencephalograph
EXTENDED LAN UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-124A
In Commercial Distribution
- 04931921108192 ()
QI-124A
- Electroencephalograph
BASE UNIT, JE-120A
NIHON KOHDEN CORPORATION
QI-123A
In Commercial Distribution
- 04931921108185 ()
QI-123A
- Electroencephalograph
EP WORKS for Protektor32 DVD
XLTEK
007135
In Commercial Distribution
- 00382830022286 ()
- Electroencephalograph
Neuroworks/Sleepworks 8.1.1 GMA3 US DVD
XLTEK
016049
In Commercial Distribution
- 00382830022279 ()
- Electroencephalograph
Neuroworks/Sleepworks 8.1.0 GMA3 Int'l DVD
XLTEK
016048
In Commercial Distribution
- 00382830022262 ()
- Electroencephalograph
NEUROWORKS 8.0.1 US DVD
XLTEK
013192
In Commercial Distribution
- 00382830022255 ()
- Electroencephalograph
NEUROWORKS 8.0.0 INTL DVD
XLTEK
012969
In Commercial Distribution
- 00382830022248 ()
- Electroencephalograph
NEUROWORKS 7.1.1 US DVD
XLTEK
005039
In Commercial Distribution
- 00382830022231 ()
- Electroencephalograph
NEUROWORKS 7.1.0 INTL DVD
XLTEK
004729
In Commercial Distribution
- 00382830022224 ()
- Electroencephalograph
Connex/Brain Monitor Breakout Box
XLTEK
012378
In Commercial Distribution
- 00382830016643 ()
- Electroencephalograph
SLEEP BREAKOUT Brain Monitor
XLTEK
003814
In Commercial Distribution
- 00382830009072 ()
- Electroencephalograph
OBM ROLL STAND KIT
XLTEK
OBM00003
In Commercial Distribution
- 00382830008020 ()
- Electroencephalograph
BRAINMONITOR W/O OXIMETER
XLTEK
10397
In Commercial Distribution
- 00382830002820 ()
- Electroencephalograph
NEUROWORKS 7.1.1 US DVD
XLTEK
005039
In Commercial Distribution
- 00382830002745 ()
- Electroencephalograph
NEUROWORKS 6.3 INTL DVD
XLTEK
002419
In Commercial Distribution
- 00382830002677 ()
- Electroencephalograph
CONNEX DIGITAL WHITE
XLTEK
10396
In Commercial Distribution
- 00382830002554 ()
- Electroencephalograph
CONNEX BREAKOUT WHITE
XLTEK
10395
In Commercial Distribution
- 00382830002547 ()
- Electroencephalograph
BRAIN MONITOR BASE WHITE
XLTEK
10388
In Commercial Distribution
- 00382830002523 ()
- Electroencephalograph
ICU DIGITAL BOX WHITE
XLTEK
10387
In Commercial Distribution
- 00382830002516 ()
- Electroencephalograph
ICU BREAKOUT BOX WHITE
XLTEK
10385
In Commercial Distribution
- 00382830002493 ()
- Electroencephalograph
Ai-Rad Companion Organs RT About Box
Siemens Healthcare GmbH
11545290
In Commercial Distribution
- 04056869274645 ()
- Radiology DICOM image processing application software
- Radiological PACS software
No Description
Siemens Healthcare GmbH
11665508
In Commercial Distribution
- 04056869973371 ()
- Radiology DICOM image processing application software
No Description
Siemens Healthcare GmbH
11665278
Not in Commercial Distribution
- 04056869955667 ()
- Radiology DICOM image processing application software
ASC Legacy™ 5.7mm-Compatible Titanium Blank
Preat Corporation
9008565
In Commercial Distribution
- 00842092183229 ()
9008565
- Dental implant suprastructure, permanent, preformed
ASC Legacy™ 4.5mm-Compatible Titanium Blank
Preat Corporation
9007565
In Commercial Distribution
- 00842092183212 ()
9007565
- Dental implant suprastructure, permanent, preformed
ASC Straumann® BLX-compatible WB Titanium Blank
Preat Corporation
9007265
In Commercial Distribution
- 00842092183205 ()
9007265
- Dental implant suprastructure, permanent, preformed
ASC Neodent® GM™ compatible Titanium Blank
Preat Corporation
9007165
In Commercial Distribution
- 00842092183199 ()
9007165
- Dental implant suprastructure, permanent, preformed
ASC Straumann® BLX-compatible RB/WB Titanium Blank
Preat Corporation
9007065
In Commercial Distribution
- 00842092183182 ()
9007065
- Dental implant suprastructure, permanent, preformed
ASC Astra® EV-compatible 5.4mm Titanium Blank
Preat Corporation
9006865
In Commercial Distribution
- 00842092183175 ()
9006865
- Dental implant suprastructure, permanent, preformed
ASC Astra® EV-compatible 4.8mm Titanium Blank
Preat Corporation
9006765
In Commercial Distribution
- 00842092183168 ()
9006765
- Dental implant suprastructure, permanent, preformed
ASC Astra® EV-compatible 4.2mm Titanium Blank
Preat Corporation
9006665
In Commercial Distribution
- 00842092183151 ()
9006665
- Dental implant suprastructure, permanent, preformed