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VERTEBROPLASTY NEEDLE KIT 8G DIAMOND TIP
SYNTHES (U.S.A.) LP
03.702.216S
Not in Commercial Distribution
- H98103702216S0 ()
- 10705034721705 ()
- 07611819371248 ()
03702216S
- Orthopaedic cement preparation/delivery kit
VERTECEM V+ SYRINGE KIT
Synthes GmbH
03.702.215S
In Commercial Distribution
- H98103702215S0 ()
- 10705034721699 ()
- 07611819396074 ()
03702215S
- Orthopaedic cement preparation/delivery kit
High-density polypropylene (HDPE) 50 mL centrifuge tubes.
LIN-ZHI INTERNATIONAL, INC.
S0000b
In Commercial Distribution
- B076S0000B1 ()
- B076S0000B0 ()
S0000b
- Drug-testing specimen collection kit IVD
ACCESS KIT-STERILE
Synthes GmbH
03.804.612S
In Commercial Distribution
- H98103804612S0 ()
- 10705034810881 ()
03804612S
- Orthopaedic cement preparation/delivery kit
Sunquest Mitogen™ Genetics supports laboratories in the management of patient genetic testing data, support reporting that includes variant information, and to transfer, store, and display test results and information.
CliniSys, Inc
6.3
Not in Commercial Distribution
- B236SMG6300 ()
- Human genomic analysis interpretive software
Medis Suite XA is software intended to be used for performing calculations in X-ray angiographic images of the chambers of the heart and of blood vessels. These calculations are based on contours that are either manually drawn by the clinician or trained medical technician who is operating the software, or automatically detected by the software and subsequently presented for review and manual editing. Medis Suite XA is also intended to be used for performing caliper measurements. The results obtained are displayed on top of the images and provided in reports.
The analysis results obtained with Medis Suite XA are intended for use by cardiologists and radiologists:
• to support clinical decisions concerning the heart and vessels
• to support the evaluation of interventions or drug therapy applied for conditions of the heart and vessels
Medis Medical Imaging Systems B.V.
2018
- Laboratory instrument/analyser application software IVD
Medis Suite XA 2023 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2023 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2023
- Laboratory instrument/analyser application software IVD
Medis Suite XA 2022 is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease. When the quantified results provided by Medis Suite XA 2022 are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2022
- Laboratory instrument/analyser application software IVD
Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease.
When the quantified results provided by Medis Suite XA are used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2021
- Laboratory instrument/analyser application software IVD
Medis Suite XA is indicated for use in clinical settings where validated and reproducible quantified results are needed to support the calculations in X-ray angiographic images of the chambers of the heart and of blood vessels, for use on individual patients with cardiovascular disease.
XA2D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, they can be used to support the clinical decisions making for the diagnosis of the patient or the evaluation of the treatment applied. In this case, the results are explicitly not to be regarded as the sole, irrefutable basis for clinical diagnosis, and they are only intended for use by the responsible clinicians.
XA3D: When the quantified results provided by Medis Suite XA is used in a clinical setting on X-ray images of an individual patient, the results are only intended for use by the responsible clinicians.
Medis Medical Imaging Systems B.V.
2020
- Laboratory instrument/analyser application software IVD