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The Falcon MD is an interactive medical image display software device for diagnostic image viewing of radiological images for the following modalities: X-ray, CT, MRI, Ultrasound, and XA for iOS and iPadOS platforms. The technological characteristics and the indications of use are identical to those of the Horos MD™ (K232589). The subject device provides both 2D and 3D image visualization tools for CT and MRI scans from various makes and models of image acquisition hardware. It does not produce any original medical images and does not contain controls for the direct operation of a diagnostic imaging system. The device is intended to be operated by radiologists, clinicians and other qualified physicians.
ICAT SOLUTIONS LTD
HOROS MOBILE
In Commercial Distribution
- 05070002336815 ()
- Radiology picture archiving and communication system workstation
The eVox System is intended for the acquisition, display, and storage, of electrical activity
of a patient’s brain including electroencephalograph (EEG) and event-related potentials
(ERP) obtained by placing two or more electrodes on the head to aid in diagnosis
The medical system includes the “eVox System” amplifier device, accessories, and a
computer (laptop computer or tablet device with internal battery and power cord).
The hardware and ancillary components used in conjunction with the eVox System include
an EEG cap, the eVox Amplifier, a charging kit (that consists of a USB cable, clip kit, and
wall adapter), a Subject Response Device and a Base Station laptop computer. The
software on the Base Station laptop computer is intended for device functioning
EVOKE NEUROSCIENCE, INC.
EVO-002-400-000
In Commercial Distribution
- 00867606000304 ()
- Electroencephalograph
IntelliSpace Radiology is a software package intended to be used by trained professionals, including
but not limited to physicians, administrators and medical technicians.
The software is used with general purpose computing hardware for the presentation, processing,
measurement and distribution of images and associated data throughout a clinical environment.
IntelliSpace Radiology software supports receiving, sending, printing, and displaying studies received
from the following modality types via DICOM: CT, MR, NM, US, XA, PET, CR, DX, DR, RF, RT, MG,
SC, VL, and OP as well as hospital/radiology information systems.
IntelliSpace Radiology contains an Advanced Mammography module for functionality specific to
Mammography. Lossy compressed mammographic images and digitized film/screen images must not
be reviewed for primary image interpretations.
Philips Medical Systems Nederland B.V.
IntelliSpace Radiology - 4
In Commercial Distribution
- 00884838123809 ()
836344
- Radiology picture archiving and communication system workstation
The AuDX Pro Otoacoustic Emissions Measurement System is a handheld battery operated device that performs otoacoustic emissions tests. Connection to the patient's ear is via the Bio-logic ear probe. Using a combination of hardware and software, the system produces a controlled acoustic signal in the ear canal and measures the resultiing evoked emissions that are generated by the outer hair cells of the inner ear associated with normal cochlear function. The stimuli are presented via miniature receivers and the acoustic response in the external ear canal is recorded via a miniature microphone, all embedded in the Bio-logic OAE probe. The system collects and averages data samples until specified measurement parameters are achieved.
NATUS MEDICAL INCORPORATED
AuDX Pro
In Commercial Distribution
- 00382830001595 ()
580-AXPRO1
- Evoked-potential audiometer
WellSky Transfusion 2024 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2024 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device
(bidirectional) WellSky Transfusion 2024 provides customized control processes for transfusion management of all procedures
and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2024
In Commercial Distribution
- B105TRANSFUSION20240 ()
- Blood bank information system application software
WellSky Transfusion 2023 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2023 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device
(bidirectional) WellSky Transfusion 2023 provides customized control processes for transfusion management of all procedures
and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2023
Not in Commercial Distribution
- B105TRANSFUSION2023 ()
- Blood bank information system application software
WellSky Transfusion 2021 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2021 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage device (bi-directional)
WellSky Transfusion 2021 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2021
In Commercial Distribution
- B105TRANSFUSION2021 ()
- Blood bank information system application software
WellSky Tranfusion 2020 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling. There is no hardware or other components included in the final product.WellSky Transfusion 2020 is intended to address all phases of transfusion services activities, and assists transfusion service personnel:
• Manipulate and label products
• Print ISBT 128 blood labels
• Perform electronic cross match
• Issue blood products under normal and emergency conditions
• Receive and test patient and unit specimens
• Interface to blood bank testing instruments (bi-directional)
• Interface to blood storage device (bi-directional)
WellSky Transfusion 2020 provides customized control processes for transfusion management of all procedures and testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2020
In Commercial Distribution
- B105TRANSFUSION2020 ()
- Blood bank information system application software
WellSky Transfusion 2022 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.WellSky Transfusion 2022 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)
WellSky Transfusion 2022 provides customized control processes for transfusion management of all procedures and
testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2022
In Commercial Distribution
- B105TRANSFUSION0 ()
- Blood bank information system application software
HCLL 2015R2 is a Blood Establishment Computer Software Product. Other than the packaging material/labeling.
There is no hardware or other components included in the final product.HCLL 2015R2 is intended to address all
phases of transfusion services activities, and assists transfusion service personnel: • Manipulate and label products • Print ISBT
128 blood labels • Perform electronic cross match • Issue blood products under normal and emergency conditions • Receive and
test patient and unit specimens • Interface to blood bank testing instruments (bi-directional) • Interface to blood storage device (bidirectional)
HCLL 2015R2 provides customized control processes for transfusion management of all procedures and
testing on products and patients to reduce human error and enhance the ability to assure patient and product safety.
WELLSKY CORPORATION
2015R2
In Commercial Distribution
- B105HCLL0 ()
- Blood bank information system application software