3 results
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18ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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VITROS Chemistry Products White Reference Slides, White Correction Factor Slide (WCF), DT Slides, 25 Slides, Part Number J02315; Made in USA by Ortho- Clinical Diagnostics, Inc. 100 Indigo Creek Drive, Rochester, NY 14626 --- This product is a part/ tool used when performing the correction factors adjustment on the VITROS Chemistry Systems. It does not have a 510(k) number. Because the WCF slide is a part/ tool, and is not a device used for diagnostic testing, there is no Intended Use statement. The following summary is provided as a description/ explanation of the WCF slide. The WCF slide is a part/ tool used in the reflectometer correction factor adjustment procedure in order to optimize the optical calibration of the VITROS 250/350/5,1 FS/4600 Chemistry Systems and the VITROS 5600 Integrated
FDA Enforcement
Class II
·Terminated·Ortho-Clinical Diagnostics·March 26, 2014
Varian brand Varian ARIA Oncology Information System, Import Export application, v 11.0; Reference/FSCA Identifier: CP-08847; Model Number: HIT; Product is manufactured and distributed by Varian Medical Systems Inc., Palo Alto, CA The ARIA Radiation Oncology product is a treatment plan and image management application. It enables the authorized user to enter, access, modify, store and archive treatment plan and image data from diagnostic studies, treatment planning, simulation, plan verification and treatment. ARIA Radiation Oncology also stores the treatment histories including dose delivered to defined sites and provides tools to verify performed treatments. ARIA also includes optional tools to manage the oncology department's clinical and business information.
FDA Enforcement
Class II
·Terminated·Varian Medical Systems, Inc. Oncology Systems·August 15, 2012
Biograph mCT Systems: (a) Biograph mCT S(64)-3R, Material Number 10248669 Product Usage: The Siemens Biograph mCT and Biograph mCT Flow systems are combined X-Ray Computed Tomography (CT) and Positron Emission Tomography (PET) scanners that provide registration and fusion of high resolution physiologic and anatomic information. The CT component produces cross-sectional images of the body by computer reconstruction of X-Ray transmission data from either the same axial plane taken at different angles or spiral planes taken at different angles. The PET subsystem images and measures the distribution of PET radiopharmaceuticals in humans for the purpose of determining various metabolic (molecular) and physiologic functions within the human body and utilizes the CT for fast attenuation correction maps for PET studies and precise anatomical reference for the fused PET and CT images. The system maintains independent functionality of the CT and PET devices, allowing for single modality CT and / or PET diagnostic imaging. These systems are intended to be utilized by appropriately trained health care professionals to aid in detecting, localizing, diagnosing, staging and restaging of lesions, tumors, disease and organ function for the evaluation of diseases and disorders such as, but not limited to, cardiovascular disease, neurological disorders and cancer. The images produced by the system can also be used by the physician to aid in radiotherapy treatment planning and interventional radiology procedures. (b) Biograph mCT S(40)-4R, Material Number 10248671 (c) Biograph mCT S(64)-4R, Material Number 10248672 (d) Biograph mCT X-4R, Material Number 10248670 (e) Biograph mCT X-3R, Material Number 10248673 (f) BIOGRAPH mCT 20 Excel, Material Number 10507786 (g) Biograph mCT Flow Edge-4R, Material Number 10528955 (h) Biograph mCT S(40)-3R, Material Number 10248668 (i) Bio mCT-S(40) 3R->4R Upgrade, Material Number 10250743 (j) Biograph mCT Flow 40-4R, Material Number 10529159 (k) Biograph mCT-X w/TrueV Upgrade, Material Number 10250745
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc.·June 27, 2018