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No Description
LINKVERSE SRL
GGM100.US
In Commercial Distribution
- 08055060110314 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
CPRO40.US
In Commercial Distribution
- 78055060110290 ()
- 08055060110291 ()
- Endoscopic video image interpretive software
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110185 ()
FS01
- Foot-switch, electrical
No Description
LINKVERSE SRL
Accessory to GI Genius
In Commercial Distribution
- 08055060110178 ()
UKS01
- Foot-switch, electrical
No Description
LINKVERSE SRL
4.0.1-S
In Commercial Distribution
- 78055060110375 ()
- 08055060110376 ()
CPRO401S-US
- Endoscopic video image interpretive software
Software to be used in GI Genius™ systems.
LINKVERSE SRL
4.0.1
In Commercial Distribution
- 78055060110344 ()
- 08055060110345 ()
CPRO401-US
- Endoscopic video image interpretive software
GI Genius™ system with software ColonPRO™.
LINKVERSE SRL
GGM300-US
In Commercial Distribution
- 08055060110338 ()
- Endoscopic video image interpretive unit
No Description
LINKVERSE SRL
GGM200.US
In Commercial Distribution
- 08055060110321 ()
- Endoscopic video image interpretive unit
This Software as a Medical Device provides a user with automatic contouring of delayed enhancement and ejection fractions studies. Ejection fraction studies are segmented in short axis views for verification and accuracy.
Terarecon Inc.
Cardiac.Chambers.MR01
In Commercial Distribution
- CARDIACCHAMBERSMR1 ()
CARDIACCHAMBERSMR1
- Radiology DICOM image processing application software
No Description
EOS IMAGING
2.1
In Commercial Distribution
- 03663999000337 ()
- Basic diagnostic x-ray system application software
No Description
EOS IMAGING
1.0
Not in Commercial Distribution
- 03663999000290 ()
- Basic diagnostic x-ray system application software
ECG iPhone App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649293 ()
- Cardiopulmonary physiological parameter analysis software
ECG Watch App (version 2.0)
APPLE INC.
Feature Version 2.x
In Commercial Distribution
- 00190199649286 ()
- Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909541 ()
- Cardiopulmonary physiological parameter analysis software
No Description
APPLE INC.
Feature Version 1.x
In Commercial Distribution
- 00190198909534 ()
- Cardiopulmonary physiological parameter analysis software
No Description
GLEAMER
1.0.X
In Commercial Distribution
- 03770020839108 ()
- Radiological PACS software
Transpara® software is intended for use as a concurrent reading aid for physicians interpreting screening full-field digital mammography exams and digital breast tomosynthesis exams from compatible FFDM and DBT systems, to identify regions suspicious for breast cancer and assess their likelihood of malignancy. Output of the device includes locations of calcifications groups and soft-tissue regions, with scores indicating the likelihood that cancer is present, and an exam score indicating the likelihood that
cancer is present in the exam. Patient management decisions should not be made solely on the basis of analysis by Transpara®.
Screenpoint Medical B.V.
2.Y.Z
In Commercial Distribution
- 08720387058044 ()
- X-ray image interpretive software
No Description
Visage Imaging GmbH
1.0
In Commercial Distribution
- 04251332930008 ()
- Radiological PACS software
AUTOMATED RADIOLOGICAL IMAGE PROCESSING SOFTWARE
Medipixel
V1.0.0
In Commercial Distribution
- 08800127400040 ()
- Radiology DICOM image processing application software
ClariSIGMAM is a software application intended for use with compatible full field digital mammography systems. ClariSIGMAM calculates percent breast density defined as the ratio of fibroglandular tissue to total breast area estimates. ClariSIGMAM provides these numerical values along with breast density category in BI-RADS 5th Edition to aid radiologists in the assessment of breast tissue composition. ClariSIGMAM produces adjunctive information. It is not an interpretive or diagnostic aid.
ClariPI Inc.
1.1.7
In Commercial Distribution
- 08800046800013 ()
- Radiology DICOM image processing application software
The Fitbit ECG App is a software-only mobile medical application intended for use with Fitbit wrist-wearable devices to create, record, store, transfer, and display a single channel electrocardiogram (ECG) qualitatively similar to a Lead I ECG. The Fitbit ECG App determines the presence of atrial fibrillation (AFib) or sinus rhythm on a classifiable waveform. The AF detection function is not recommended for users with other known arrhythmias.
The Fitbit ECG App is intended for over-the-counter (OTC) use. The ECG data displayed by the ECG Spot Check is
intended for informational use only. The user is not intended to interpret or take clinical action based on the device output without consultation of a qualified healthcare professional. The ECG waveform is meant to supplement rhythm classification for the purposes of discriminating AFib from normal sinus rhythm and is not intended to replace traditional methods of diagnosis or treatment. The Fitbit ECG App is not intended for use by people under 22 years old
FITBIT, INC.
FB603
In Commercial Distribution
- 00810038851983 ()
- Cardiopulmonary physiological parameter analysis software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_UI
In Commercial Distribution
- 07290019352037 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Seamless
In Commercial Distribution
- 07290019352020 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Mobile
In Commercial Distribution
- 07290019352013 ()
- Ultrasound imaging system application software
No Description
DIA IMAGING ANALYSIS LTD
Lvivo_Platform
In Commercial Distribution
- 07290019352006 ()
- Ultrasound imaging system application software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution
- 17540262150018 ()
- Radiological PACS software
SW B36104S SURETUNE4 DBS SERVER
MEDTRONIC, INC.
B36104S
In Commercial Distribution
- 00763000421212 ()
- 00763000496456 ()
- Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT
MEDTRONIC, INC.
B36104C
In Commercial Distribution
- 00763000421212 ()
- 00763000496449 ()
- Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE
MEDTRONIC, INC.
B36104A
In Commercial Distribution
- 00763000421212 ()
- 00763000496432 ()
- Implantable electrical stimulation device management software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.5.y.z
In Commercial Distribution
- 07290018052280 ()
- Radiology DICOM image processing application software