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LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter
BUTTERFLY NETWORK, INC.
490-00183-02, 490-00189-02
Not in Commercial Distribution
- 00866646000305 ()
- Hand-held ultrasound imaging system, body-surface
USB-C CABLE ASSEMBLY, USB 3.1 GEN 1, 1.50 meter
BUTTERFLY NETWORK, INC.
490-00192-02
In Commercial Distribution
- 00866646000299 ()
- Hand-held ultrasound imaging system, body-surface
USB-C CABLE ASSEMBLY, USB 2.0, 1.50 meter
BUTTERFLY NETWORK, INC.
490-00187-02
In Commercial Distribution
- 00866646000282 ()
- Hand-held ultrasound imaging system, body-surface
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.50 meter
BUTTERFLY NETWORK, INC.
490-00183-02, 490-00189-02
In Commercial Distribution
- 00866646000275 ()
- Hand-held ultrasound imaging system, body-surface
BUTTERFLY iQ/iQ+ WIRELESS CHARGER KIT
BUTTERFLY NETWORK, INC.
WTD1A05
In Commercial Distribution
- 00866646000268 ()
- Hand-held ultrasound imaging system, body-surface
LIGHTNING CABLE ASSEMBLY, USB 2.0, 2.00 meter
BUTTERFLY NETWORK, INC.
490-00183-01, 490-00189-01
In Commercial Distribution
- 00866646000251 ()
- Hand-held ultrasound imaging system, body-surface
LIGHTNING CABLE ASSEMBLY, USB 2.0, 1.25 meter
BUTTERFLY NETWORK, INC.
490-00183-00, 490-00189-00
In Commercial Distribution
- 00866646000244 ()
- Hand-held ultrasound imaging system, body-surface
USB-C CABLE ASSEMBLY, USB 2.0, 2.00 meter
BUTTERFLY NETWORK, INC.
490-00187-01
In Commercial Distribution
- 00866646000237 ()
- Hand-held ultrasound imaging system, body-surface
USB-C CABLE ASSEMBLY, USB 2.0, 1.25 meter
BUTTERFLY NETWORK, INC.
490-00187-00
In Commercial Distribution
- 00866646000220 ()
- Hand-held ultrasound imaging system, body-surface
BUTTERFLY iQ+
BUTTERFLY NETWORK, INC.
850-20014
In Commercial Distribution
- 00866646000213 ()
- Hand-held ultrasound imaging system, body-surface
Standard Imaging QA Pilot is cloud-based software tool that allows users to enter, store, and analyze data accumulated in the clinical radiation oncology setting from quality assurance processes.
STANDARD IMAGING INC.
91348
In Commercial Distribution
- 00866562000298 ()
91348
- Radiation therapy software
Standard Imaging RAy Software is a film dosimetry application, designed to perform one-dimensional, two-dimensional, and three-dimensional analyses of dose deposition pattern on film under specific mega-voltage irradiation setups.
STANDARD IMAGING INC.
91336
In Commercial Distribution
- 00866562000274 ()
91336
- Radiation therapy software
Standard Imaging LinacView Software is a stand alone software medical device used for logfile analysis of radiation therapy systems.
STANDARD IMAGING INC.
91330
In Commercial Distribution
- 00866562000267 ()
91330
- Radiation therapy software
Standard Imaging Adaptivo Software is a stand alone software medical device used for QA checks of comparative and cumulative dose received during radiation treatment from radiation therapy systems.
STANDARD IMAGING INC.
v1
In Commercial Distribution
- 00866562000243 ()
91350
- Radiation therapy software
Standard Imaging PIPSpro Software is a stand alone software medical device used for QA checks of imaging systems used with radiation therapy systems.
STANDARD IMAGING INC.
v5
In Commercial Distribution
- 00866562000236 ()
91309
- Radiation therapy software
Standard Imaging IMSure QA Software is a stand alone software medical device used for monitor unit secondary checks and IMRT treatment plan secondary checks of radiation treatment plans from radiation therapy systems.
STANDARD IMAGING INC.
v3
In Commercial Distribution
- 00866562000229 ()
91326
- Radiation therapy software
NON INVASIVE BLOOD PRESSURE NYLON CUFF CHILD DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177809D
In Commercial Distribution
- 00866512000293 ()
177809D
- Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF SMALL CHILD DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177808D
In Commercial Distribution
- 00866512000286 ()
177808D
- Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF INFANT DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177807D
In Commercial Distribution
- 00866512000279 ()
177807D
- Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEW BORN DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177806D
In Commercial Distribution
- 00866512000262 ()
177806D
- Blood pressure cuff, reusable
NON INVASIVE BLOOD PRESSURE NYLON CUFF NEONATE #5 DOUBLE TUBE
KENTRON HEALTHCARE, INC.
177805D
In Commercial Distribution
- 00866512000255 ()
177805D
- Blood pressure cuff, reusable
The Radiation Analyzer (RAy)is a film dosimetry application used to verify complex radiation therapy treatment plans.
AGILE RADIOLOGICAL TECHNOLOGIES
5.0
Not in Commercial Distribution
- 00866498000300 ()
Ray 5.0
- Radiation therapy software
Instrument Cannula
Cannuflow, Inc.
EX-8-7T
In Commercial Distribution
- 20866497000329 ()
- 00866497000325 ()
- Lumen/Inner Diameter: 8 Millimeter
EVEX-8-7T
- Arthroscopic access cannula, single-use
Flexible Inflow-Outflow Cannula
Cannuflow, Inc.
CV27-S
In Commercial Distribution
- 20866497000312 ()
- 00866497000318 ()
- Lumen/Inner Diameter: 2.7 Millimeter
CV27-S
- Arthroscopic access cannula, single-use
Flexible Inflow-Outflow Cannula
Cannuflow, Inc.
CV27-B
In Commercial Distribution
- 20866497000305 ()
- 00866497000301 ()
- Lumen/Inner Diameter: 2.7 Millimeter
CV27-B
- Arthroscopic access cannula, single-use
The Procleix Xpress System v3.2 (Software and Instrument) is intended to be used to create whole blood lysates and pools of whole blood lysate for blood screening tests for nucleic acids. The Procleix Xpress System automatically creates the lysate by adding whole blood to a lysis buffer. The resulting lysates may then be transferred into a single master pool tube. The pooled or individual lysates may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes and racks used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.2
In Commercial Distribution
- 00866489000098 ()
741743
- Nucleic acid sample preparation instrument IVD, semi-automated
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System (software and instrument) is intended to be used to create pools of human plasma or serum for blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
Version 3.0
In Commercial Distribution
- 00866489000036 ()
740769
- Pipetting system
The Procleix Software is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
718463
In Commercial Distribution
- 00866489000012 ()
718463
- Electronic pipette
The Procleix Pipettor is one part of the Procleix Xpress System. The Procleix Xpress System is intended to be used to create pools of human plasma or serum for in vitro diagnostic testing, such as blood screening tests for viral nucleic acids. The Procleix Xpress System automatically transfers plasma or serum from individual samples into a single master pool tube, which may be used for further testing in Procleix systems. The Procleix Xpress System also collects barcode data from all tubes, racks, and archive plates used in a given pooling run, establishing positive specimen identification and Master Pool Tube (MPT) composition. In addition, the Procleix Xpress System can be used to dispense human plasma or serum aliquots into an archive plate.
GRIFOLS DIAGNOSTIC SOLUTIONS INC.
30055067
In Commercial Distribution
- 00866489000005 ()
30055067
- Electronic pipette
STAGE is a MR post-processing software medical device intended for use in the visualization of the brain. STAGE analyzes input data from MR imaging systems. STAGE runs within a VM environment on hardware that meets the minimum requirements. STAGE utilizes magnitude and phase data acquired with specific parameters to generate enhanced T1 weighted images, SWI images, susceptibility enhanced images, pseudo-susceptibility maps, true SWI images, MR angiography (MRA) images, simulated T2 images, simulated T2 FLAIR images, simulated dual inversion recovery (DIR) images, and maps of T1, R2*, and proton density (PD). CROWN, introduced in STAGE, reduces noise some of these outputs, enhancing SNR and/or reducing imaging time. STAGE is indicated for brain imaging. Maximum and minimum intensity projections of some of these outputs will also be provided. The STAGE outputs can be configured to match the conventional acquisition series in MR protocols (i.e. routine brain w/) in terms of contrast, orientation and resolution.
STAGE should always be used in combination with at least one other conventional MR acquisition technique (e.g. T2 FLAIR). STAGE input data can be acquired within a range of collection parameters, within shorter echo acquisitions allowing for less susceptibility affects and higher anatomic signal at the air tissue interface or with longer echo times for higher susceptibility effects around blood products and iron sources.
Spintech, Inc.
2.3
In Commercial Distribution
- 00866463000465 ()
REF 200008
- MRI system application software