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INVACARE ISA COMPACT STAND-UP LIFT
INVACARE CORPORATION
ISACOMPACT
In Commercial Distribution
- 05600494138712 ()
- Mobile patient lifting system, electrically-powered
INVACARE ISA XPLUS STAND-UP LIFT
INVACARE CORPORATION
ISAXPLUS
In Commercial Distribution
- 05600494138705 ()
- Mobile patient lifting system, electrically-powered
AI4CMR v1.0 is a cloud-hosted service used with any third-party DICOM viewer applicationwhere the DICOM viewer serves as the user interface and the interface to a PACS or scanner forAI4CMR. AI4CMR is implemented as a plug-in to the DICOM viewer by the user andautomatically processes and analyses cardiac MR images received by the DICOM viewer toquantify relevant cardiac function metrics and makes the information available to the user at theuser’s discretion
Indications for use:
AI4CMR software is designed to report cardiac function measurements (ventricle volumes, ejection fraction, indices etc.) from 1.5T and 3T magnetic resonance (MR) scanners. AI4CMR uses artificial intelligence to automatically segment and quantify the different cardiac measurements. Its results are not intended to be used on a stand-alone basis for clinical decision-making.
The user incorporating AI4CMR into their DICOM application of choice is responsible for implementing a user interface.
AI4MEDIMAGING - MEDICAL SOLUTIONS, S.A.
v1.0
In Commercial Distribution
- 05600250059022 ()
- MRI system application software
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7053008-100
In Commercial Distribution
- 10850011833565 ()
- 00850011833568 ()
- 80850011833564 ()
- Insulin syringe/needle, basic
The proposed device Insulin Syringe, a sterile device consisting of a calibrated barrel with plunger, is intended to be used to administer an injection of insulin to a patient subcutaneously. A non-retractable integrated needle is included. The syringe is made of plastic and silicone materials and allowing smooth plunger movement.
This is a single-use device. The device is the same as K193273. The purpose of the submission is to add OTC labeling.
Promisemed Medical Devices Inc.
ISY-7033108-100
In Commercial Distribution
- 10850011833558 ()
- 00850011833551 ()
- 80850011833557 ()
- Insulin syringe/needle, basic
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE30x40
In Commercial Distribution
- 00850011613160 ()
- 30mm x 40mm
- Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE20x30
In Commercial Distribution
- 00850011613153 ()
- 20mm x 30mm
- Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEODE15x20
In Commercial Distribution
- 00850011613146 ()
- 15mm x 20mm
- Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD30x40
In Commercial Distribution
- 00850011613054 ()
- 30mm x 40mm
- Collagen dental regeneration membrane
Resorbable Collagen Membrane
COLLAGEN MATRIX, INC.
OSTEOD20x30
In Commercial Distribution
- 00850011613047 ()
- 20mm x 30mm
- Collagen dental regeneration membrane