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Ceevra Reveal 3+ (“Reveal 3+”), manufactured by Ceevra, Inc. (the “Company”), is a software as a medical device with two main functions: (1) it is used by Company personnel to generate three-dimensional (3D) images from existing patient CT and MR imaging, and (2) it is used by clinicians to view and interact with the 3D images during preoperative planning and intraoperatively.
Clinicians view 3D images via the Reveal 3+ Mobile Image Viewer software application which runs on compatible mobile devices, and the Reveal 3+ Desktop Image Viewer software application which runs on compatible computers. The 3D images may also be displayed on compatible external displays, or in virtual reality (VR) format with a compatible off-the-shelf VR headset.
Reveal 3+ includes features that enable clinicians to interact with the 3D images including rotating, zooming, panning, selectively showing or hiding individual anatomical structures, and viewing measurements of or between anatomical structures.
Ceevra, Inc.
3+
In Commercial Distribution
- 00861625000437 ()
- Image segmentation application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
VA3
In Commercial Distribution
- 04068151027013 ()
- PET system application software
- SPECT system application software
No Description
SIEMENS MEDICAL SOLUTIONS USA, INC.
11589501
In Commercial Distribution
- 04068151009477 ()
- PET system application software
- SPECT system application software
Brainlab Elements Guide XT is a software application designed to support neurosurgeons and neurologists in Deep Brain Stimulation (DBS) treatments. It enables stimulation field simulation and visualization of the stimulation field model in the context of anatomical images. This functionality can be used to aid in lead parameter adjustment in the context of minimally invasive cranial neurological procedures.
Brainlab Elements Guide XT is used in combination with other applications that provide functionality for image fusion, segmentation, etc.
Guide XT is compatible with selected Boston Scientific leads and implantable pulse Generators but does not directly interact with the surgeon.
Brainlab AG
3.0
In Commercial Distribution
- 04056481142032 ()
- Implantable electrical stimulation device management software
Clever One is a dental imaging software designed to acquire, process, view, edit, and analyze medical images for supporting diagnostic and preoperative planning purposes. It supports standard DICOM formats for 2D and 3D image files and enables advanced imaging functionalities for enhanced diagnostic accuracy.
The software provides a range of features, including:
- 2D Imaging: Loading, editing, and viewing 2D dental images in standard formats (e.g., DICOM, JPG, BMP).
- 3D Imaging: Visualization and reconstruction of 3D CT images, including multi-planar views (MPR) and volume rendering.
- Preoperative Planning: Implant position simulation, canal drawing, and bone density analysis to support treatment planning.
- Data Interoperability: Facilitates data transfer and storage using DICOM-compliant workflows, ensuring compatibility with third-party systems and imaging devices.
The software interfaces with dental imaging equipment, such as CT, panoramic, cephalometric, and intraoral X-ray systems, as well as intraoral cameras, for image
acquisition. It is designed for use in network environments, allowing users to upload and download clinical diagnostic images and patient data for enhanced collaboration and efficient patient management.
EWOO SOFT Co., Ltd
1.0
In Commercial Distribution
- 08800019700593 ()
- General-purpose dental x-ray system 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
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
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
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
Burn Navigator RX
ARCOS, INC.
RX
In Commercial Distribution
- B2551143 ()
1143
- Clinical information system web-based application software
Burn Navigator H2 Transport
ARCOS, INC.
H2 Transport
In Commercial Distribution
- B2551125 ()
1125
- Clinical information system web-based application software
Burn Navigator H2 model
ARCOS, INC.
H2
In Commercial Distribution
- B2551120 ()
1120
- Clinical information system web-based application software
Viz Subdural+ v1.1 (2025-07-10)
VIZ.AI, INC.
Viz Subdural+ Software
In Commercial Distribution
- 00811852030363 ()
- Radiology DICOM image processing application software
Viz ICH+ v1.3 (2025-04-06)
VIZ.AI, INC.
Viz ICH+ Software
In Commercial Distribution
- 00811852030349 ()
- Radiology DICOM image processing application software
Viz HCM v1.1 (2024-06-19)
VIZ.AI, INC.
Viz HCM Software
In Commercial Distribution
- 00811852030332 ()
- Cardiopulmonary physiological parameter analysis software
Viz RV/LV v1.2 (2023-04-19)
VIZ.AI, INC.
Viz RV/LV Software
In Commercial Distribution
- 00811852030295 ()
- Radiology DICOM image processing application software
TeraRecon Aorta.CT is intended to provide an automatic 3D segmentation and label anatomical landmarks of the Aorta. The results of TeraRecon Aorta.CT are intended to be used in conjunction with other patient information by trained professionals who are responsible for making any patient management decision per the standard of care.
Terarecon Inc.
Aorta.CT01
In Commercial Distribution
- AORTACT01 ()
Aorta.CT
- Radiology DICOM image processing application software
No Description
STRYKER CORPORATION
01030300
In Commercial Distribution
- 07613327459081 ()
0103-0300
- Radiology DICOM image processing application software
No Description
STRYKER CORPORATION
3105001000
In Commercial Distribution
- 07613327382570 ()
3105001000
- 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
POSTOPERATIVE TLHEXMODULE VERSION 1.1 FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution
- 18059015375848 ()
TLHEXMODULESW1.1
- Radiological PACS 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
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.4.x.y
In Commercial Distribution
- 07290018052266 ()
- Radiology DICOM image processing application software
BriefCase-Quantification is an Automated Radiological Image Processing Software.
AIDOC MEDICAL LTD
BC.QTF.3.x.y
In Commercial Distribution
- 07290018052235 ()
- Radiology DICOM image processing application software
PREOPERATIVE JPS MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.1
In Commercial Distribution
- 18053340345682 ()
JPSMODULESW
- Radiological PACS software
PREOPERATIVE FITBONE MODULE FOR ORTHONEXT SOFTWARE
ORTHOFIX SRL
1.0
In Commercial Distribution
- 18052469470008 ()
FITBONEMODULESW
- Radiological PACS software
No Description
Chengdu Wision Medical Device Co., Ltd.
WIPD01
In Commercial Distribution
- 06973770840012 ()
- Endoscopic video image interpretive software
No Description
Change Healthcare Canada Company
1.0.0
In Commercial Distribution
- 17540262150018 ()
- Radiological PACS software
SW B36104S SURETUNE4 DBS SERVER MDR
MEDTRONIC, INC.
B36104S
In Commercial Distribution
- 00763000990442 ()
- Implantable electrical stimulation device management software
SW B36104C SURETUNE4 DBS CLIENT MDR
MEDTRONIC, INC.
B36104C
In Commercial Distribution
- 00763000990435 ()
- Implantable electrical stimulation device management software
SW B36104A SURETUNE4 DBS STANDALONE MDR
MEDTRONIC, INC.
B36104A
In Commercial Distribution
- 00763000990428 ()
- Implantable electrical stimulation device management 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
Software, Version 1.0.0.4, Treatment Delivery Console, Radixact
(Operating Software for Radixact Treatment Delivery System)
ACCURAY INCORPORATED
1057727
In Commercial Distribution
- M65810577270 ()
NA
- Linear accelerator system
VITEK®2 software 9.01.0, advanced software to run your VITEK®2 system
BIOMERIEUX , INC.
9.01.0
Not in Commercial Distribution
- 03573026555504 ()
- Microorganism identification/antimicrobial-susceptibility analyser IVD
360CAS Navigation System Software is a bespoke software developed by Kico for surgical navigation.
KICO KNEE INNOVATION COMPANY PTY LIMITED
2.2.0
In Commercial Distribution
- B432360CAS2200 ()
- Robotic surgical navigation system application software