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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
Intuition (also referred to as Aquarius Intuition) is a medical device comprised of two stand-alone software components: a server software backend (Intuition Server) which performs complex image post processing and client viewer software (Intuition Client Viewers) that provides a user interface, enabling the user to view medical image data and associated derived metadata. The Intuition client viewer/server software enables 2D/3D/4D (3D with the dimension of time) image review, volume rendering, communications, storage, reporting, and image post processing. The Intuition software is used with off-the-shelf hardware, including a computer, monitor, keyboard and mouse.
Intuition is comprised of six (6) separate client viewers: Intuition Client with Emergency Lung Docker, Intuition Thin Client, Intuition Review, Intuition EMV, Intuition Web Viewer, and Intuition Mobile.
Terarecon Inc.
Intuition04
In Commercial Distribution
- INTUITION04 ()
Intuition
- Radiology DICOM image processing application software
The Emerald Herbst appliance is a customized oral device featuring both lower and upper trays and interlocking system. The product is non-sterile, biocompatible, and provided in a sealed box with instructions for use. The upper and lower trays are connected by an adjustable hinge allowing the patient to open and close the mouth while wearing the appliance. The Herbst Telescopic Hardware on the side of the device allows the patient to move forward and left and right but not backwards. This freedom of movement is important for comfort and overall success of the device.
The Emerald Herbst appliance treats snoring and mild to moderate sleep apnea by guiding the mandible forward during sleep, preventing the tongue and soft tissues of the throat from collapsing into the airway.
Island Dental Lab Inc. DBA Emerald Dental Lab
Emerald Herbst
In Commercial Distribution
- 00198168357521 ()
- Mandible-repositioning/palate-lifting sleep-disordered breathing orthosis