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Tantalum bead implants are used as radio-opaque markers and may be implanted into bone or soft tissue
Halifax Biomedical Incorporated
2
In Commercial Distribution
- 00628451892014 ()
P005603
- Radiological image marker, implantable
TIDI Positioning Aid Kits Kit, Various Sizes 8 per Set
TIDI PRODUCTS, LLC
2
Not in Commercial Distribution
- 00618125168187 ()
- Multifunction body cushion
Dental CADCAM Software
Dental Wings Inc
2
In Commercial Distribution
- D840DWOSCS1 ()
- Dental milling system, CAD/CAM, chairside
Etiometry Platform
ETIOMETRY INC.
2
In Commercial Distribution
- 00863061000309 ()
- Clinical management support software
Anesthesia Recovery Device
ANECARE, LLC
2
In Commercial Distribution
- 10863034000326 ()
- 00863034000329 ()
90020
- Anaesthesia workstation gas scavenger
vRad PACS 2
Vrad
2
In Commercial Distribution
- 00862234000313 ()
- Radiological PACS software
The Decisio Health Patient Dashboard (“Patient Dashboard”) is a data aggregation and visualization software device. The Patient Dashboard is designed to display patient information, facility specific care protocols, and visual cues to care providers on a single display device. The Patient Dashboard is configured to receive patient data through the facility’s Electronic Medical Record system and display information to the user on a patient monitor, computer, or a mobile device. Data received through the EMR includes input from various sources within the hospital, including manually entered data into the EMR (e.g., laboratory data), vital signs monitors, ventilators, IV pumps, and Foley catheter devices. The data the Patient Dashboard receives are then stored, filtered, and displayed through the Patient Dashboard web browser application. The Patient Dashboard is customized to individual facility’s care as it is programmed with the facility’s treatment protocols, which dictate the information that is displayed relative to those protocols. The device performs automated calculations on patient data collected by third party devices based on approved clinical protocols at patient care facilities.
DECISIO HEALTH, INC.
2
In Commercial Distribution
- 00865683000309 ()
- Clinical management support software
ImPACT Quick Test is intended for use as a computerized cognitive test to aid in the assessment of concussion in individuals ages 12-70
IMPACT APPLICATIONS, INC.
2
In Commercial Distribution
- 00864127000356 ()
- Cognitive assessment software
STAGE works as a comprehensive brain imaging post-processing solution. The STAGE system consists of a client supplied dedicated computer with an ethernet connection to the client’s existing local network. The STAGE software will operate within a virtual machine environment (virtual STAGE module) on this dedicated computer. The computer receives DICOM data from a specific MRI 3D GRE scan protocol (i.e., the STAGE protocol) and then outputs back numerous DICOM datasets with different types of contrast to the PACS server. The data transfer is initiated by the user’s current DICOM viewing software. STAGE has been modified from the predicate to include CROWN, a white noise filtering algorithm intended to improve specific STAGE outputs. The following table provide a summary of the methodology for each output with an example image and technical comparison to the predicate.
Spintech, Inc.
2
Not in Commercial Distribution
- 00866463000441 ()
- MRI system application software
No Description
EPIC SYSTEMS CORPORATION
2
In Commercial Distribution
- 00860475000345 ()
- Blood bank information system application software
No Description
VARIAN MEDICAL SYSTEMS, INC.
2
In Commercial Distribution
- 00850011006122 ()
ASM0341
- Radiation therapy invasive marker lesion localization system
Patient Care System (PCS)
ST. JUDE MEDICAL, INC.
2
In Commercial Distribution
- 05415067031174 ()
MER3700
- Multiple active implantable device programmer
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197004069 ()
05923450190
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197004182 ()
05989060190
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197003024 ()
05212308190
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197002706 ()
05027012190
- Hepatitis C virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197001099 ()
03322114018
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
In Commercial Distribution
- 00875197001068 ()
03302563018
- HIV1/Hepatitis C virus/Hepatitis B virus nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
Roche Molecular Systems, Inc.
2
Not in Commercial Distribution
- 00875197000993 ()
03155935018
- HIV1 nucleic acid IVD, kit, nucleic acid technique (NAT)
No Description
ORTHO KINEMATICS, INC.
2
In Commercial Distribution
- 00868579000209 ()
- Diagnostic x-ray digital imaging system workstation