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The CT 5300 is a Computed Tomography X-Ray System is intended to produce images of the head and body by computer reconstruction of X-Ray transmission data taken at different angles and planes. This device includes data acquisition system, detection management system and an operating console with display monitors along with patient and system supporting devices, accessories and components.
Philips Healthcare (Suzhou) Co., Ltd.
CT 5300
In Commercial Distribution
- 00884838113237 ()
728285
- Full-body CT system
The Incisive CT is a Computed Tomography X-Ray System intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. This device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.
Philips Healthcare (Suzhou) Co., Ltd.
Incisive CT
In Commercial Distribution
- 00884838105508 ()
728144
- Full-body CT system
IntelliSpace Portal is a software medical device that allows multiple users to remotely access clinical applications from compatible computers on a network. The system allows networking, selection, processing, archiving and filming of multimodality DICOM images. This software is for use with off-the-shelf hardware technology that meets defined minimum specifications.
Philips Medical Systems Nederland B.V.
8.x
Not in Commercial Distribution
- 00884838073876 ()
- Radiology DICOM image processing application software
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828166 ()
CL-08-0013-H2
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828159 ()
CL-08-0015-B2
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828142 ()
CL-08-0013-H4
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full-body, low-dose X-ray scanner which produce digital X-ray images used for diagnosis purpose in both trauma and general radiography cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828135 ()
CL-08-0013-A11
- Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes
in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828128 ()
CL-08-0013-H11
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828111 ()
CL-08-0015-B1
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828104 ()
CL-08-0012-A8
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828098 ()
CL-08-0012
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, X-ray scanner which produce digital X-ray images used for diagnostic purposes in both trauma and general radiology cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828081 ()
CL-08-0016-I2
- Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828074 ()
CL-08-0013-H7
- Stationary basic diagnostic x-ray system, digital
The eXero-dr is a full-body, low-dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiography cases as well as in forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
eXero-dr
In Commercial Distribution
- 06009880828067 ()
CL-08-0013-H6
- Stationary basic diagnostic x-ray system, digital
The Xmplar-dr is a full body, low dose, x-ray scanner which produce digital x-ray images used for diagnosis purposes in both trauma and general radiology cases, as well as forensic pathology cases.
LODOX SYSTEMS (PTY) LTD
Xmplar-dr
In Commercial Distribution
- 06009880828036 ()
CL-08-0012-A16
- Stationary basic diagnostic x-ray system, digital
CBCT upper & lower extremities including the pelvis
CURVEBEAM, LLC
1040-230
In Commercial Distribution
- 00860004550037 ()
- Limited-view-field CT system
iCT System 115219-000
IMRIS Imaging, Inc.
iCT System
In Commercial Distribution
- 00857534006219 ()
- Full-body CT system
IQQA-Guide is intended for intra-operative guidance for surgical procedures
EDDA TECHNOLOGY, INC.
IQQA-Guide
In Commercial Distribution
- 00868466000237 ()
- Electromagnetic surgical navigation device tracking system
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.1
In Commercial Distribution
- 00858012005915 ()
CT-102
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005908 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005892 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
VeraLook® CTC CAD Software is intended to automatically detect potential polyps in CT Colonography exams. The identified polyps can then be highlighted to the interpreting physician after initial review of the CTC exam with the intent of identifying additional potential polyps that may not have been identified on initial review.
Icad, Inc.
V1.0
In Commercial Distribution
- 00858012005885 ()
CT-102-V-US, CT-102-V, CT-103, D70070, D70071, D70147, D70148, D70158
- CT system application software
No Description
BRAINOMIX LIMITED
2.2
In Commercial Distribution
- B720BX360ELUNG220 ()
- X-ray image interpretive software
ClearRead CT CAC Docker
Riverain Technologies, Inc.
1.2.1
In Commercial Distribution
- M722CD25133CA241430 ()
- Radiological PACS software
ClearRead CT CAC Docker
Riverain Technologies, Inc.
1.2.0
In Commercial Distribution
- M722CD25030CA241430 ()
- Radiological PACS software
ClearRead CT CAC Console
Riverain Technologies, Inc.
1.2.1
In Commercial Distribution
- M722CC25133CA241430 ()
- Radiological PACS software
ClearRead CT CAC Console
Riverain Technologies, Inc.
1.2.0
In Commercial Distribution
- M722CC25030CA241430 ()
- Radiological PACS software
ClearRead CT CAC Server
Riverain Technologies, Inc.
1.2.1
In Commercial Distribution
- M722C25133CA241430 ()
- Radiological PACS software
ClearRead CT CAC Server
Riverain Technologies, Inc.
1.2.0
In Commercial Distribution
- M722C25030CA241430 ()
- Radiological PACS software
NEUWAVE AC System - 120V
NEUWAVE MEDICAL, INC.
2.45 GHz Ablation System
Not in Commercial Distribution
- 00853719006180 ()
DR-000783
- Microwave ablation system generator
No Description
XORAN TECHNOLOGIES LLC
10040
In Commercial Distribution
- 00860008443755 ()
- Cone beam computed tomography system, head/neck
No Description
XORAN TECHNOLOGIES LLC
10015
In Commercial Distribution
- 00860008443731 ()
- Cone beam computed tomography system, head/neck
VIDA Insights is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
3.x
In Commercial Distribution
- 00852426007022 ()
- CT system application software
LungPrint is an interactive software-based viewing and reporting platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
1.x
In Commercial Distribution
- 00852426007015 ()
- CT system application software
VIDA|vision is an interactive software-based viewing platform that displays image analysis results for use by pulmonary care providers in the diagnosis and documentation of pulmonary tissue images.
VIDA DIAGNOSTICS, INC.
2.x
In Commercial Distribution
- 00852426007008 ()
- CT system application software
CBCT upper & lower extremities including the pelvis
CURVEBEAM, LLC
1040-115
In Commercial Distribution
- 00860004550020 ()
- Limited-view-field CT system
The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
33
In Commercial Distribution
- 00856181003336 ()
- Electrocardiograph, professional, multichannel
The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
32
In Commercial Distribution
- 00856181003329 ()
- Electrocardiograph, professional, multichannel
The SynChron™ Wireless Vector Gating System for CT is a product used to acquire electrocardiogram (ECG) data from a patient and to generate and supply ECG waveform and triggering pulses to the CT scanner to aid in cardiac scanning. The SynChron™ Wireless Vector Gating System for CT includes a Physiologic Acquisition Module (PAM) that connects to the patient using ECG lead wires (Figure 2-2), acquires ECG data, processes the ECG data, and wirelessly transmits the data to the Receive Interface Module (RIM). The RIM will wirelessly receive data from the PAM, create analog ECG waveform and trigger pulse mark, and interfaces with the scanner. The ECG waveform and trigger marks can be seen on the scanner console.
NEOCOIL, LLC
31
In Commercial Distribution
- 00856181003312 ()
- Electrocardiograph, professional, multichannel
No Description
VARIAN MEDICAL SYSTEMS, INC.
1.0
In Commercial Distribution
- 10856100006223 ()
- 00856100006226 ()
- Real-time position management respiratory gating system, optical