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    Filters Classification: Class Ii × Regulation: Us FDA × Clear all

    Ultrasound Transducer, Model Number: UST-5550-R, is used in conjunction with a diagnostic ultrasound system evaluation during robotic and non-robotic intra-operative and laparoscopic procedures.

    FDA Enforcement
    Class II ·Terminated·Hitachi Medical Systems America Inc·March 7, 2018

    AXIOM Artis zee/zeego, system, x-ray, angiographic Product Usage: AXIOM Artis zee and Q/Q.zen is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the AXIOM Artis zee/zeego and Q/Q.zen family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. AXIOM Artis zee/zeego and Q/Q.zen can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·April 6, 2016

    Leica HistoCore Arcadia H, REF: 14039354100 and 14039357258, Paraffin Embedding Station.

    FDA Enforcement
    Class II ·Ongoing·LEICA BIOSYSTEMS NUSSLOCH GMBH·August 14, 2024

    Artis Q biplane, Model Number 10848282

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·April 27, 2022

    Computed Tomography X-Ray Systems, (Brilliance 6, Brilliance 16, MX8000 Dual v. Exp, GEMINI Dual), Philips Healthcare Systems, Cleveland, OH. The Brilliance 6, 16 and MX8000 Dual v. Exp are Computed Tomography X-Ray Systems that are intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display equipment, patient, and equipment supports, components and accessories. GEMINI Dual is an imaging system that combines positron emission tomography (PET) and X-ray computed tomography. The GEMINI produces attenuation and non-attenuation corrected images of the distribution of PET radiopharmaceuticals in the head, body and total body as well as X-ray transmission images of these areas. The PET and CT images are registered and displayed in a fused format to provide combined PET and anatomical data at different angles for interpretation by trained health professionals. The PET and CT portions of the system can be used either as an integrated system or as a stand-alone PET or CT system. GEMINI can provide CT data suitable for use in attenuation correction.

    FDA Enforcement
    Class II ·Terminated·Philips Medical Systems (Cleveland) Inc·October 3, 2012

    DynaCad software consist of an MR Analysis Server software and the viewer workstation software. The MR Analysis software consists of DynaCad Breast, DynaCad Prostate, and DynaCad Advanced PK for other MR analyses modules. Product Usage: Intended to be used as a post processing software package designed to provide a reliable means for analyzing MR datasets.

    FDA Enforcement
    Class II ·Terminated·Invivo Corporation·April 11, 2018

    Corin Operating Tables Model Numbers: (1) 770001A0, (2) 770001A2, (3) 770001B0, (4) 770001B2, (5) 770001F0, (6) 770001F2; All Software Versions.

    FDA Enforcement
    Class II ·Ongoing·MAQUET GMBH·September 3, 2025

    Carestream DRX-Revolution Mobile X-Ray System -- Made in U.S.A. by Carestream Health Inc. 150 Verona Street, Rochester, NY . 14608 --- The DRX Revolution Mobile system is a mobile diagnostic x-ray system for generation of x-rays for examination of various anatomical regions. These products are mobile diagnostic x-ray systems designed to perform radiographic x-ray examinations on all pediatric and adult patients, in all patient treatment areas.

    FDA Enforcement
    Class II ·Terminated·Carestream Health Inc.·January 15, 2014

    Artis Q Interventional Fluoroscopic X-Ray System, Model Numbers 10848280, 10848281, 10848282, 10848283, 10848354 & 10848355

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·September 26, 2018

    MultiDiagnost-Eleva, Product codes 708032, 708036 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    URODiagnost Eleva, Product codes 708026, 708027, 708028 Product Usage: The Philips OmniDiagnost is a multi-functional, universal X-ray system with remote-controlled facilities. It performs a wide range of routine examinations and interventional procedures include: Gastro-intestinal examination Urography Bronchography Arthrography Hysterography Myelography Lymphography Skeletal radiography Tomography Venography/phlebography Special procedures that require subtracted and non-subtracted digital imaginginclude: Angiography Peripheral angiography (bolus chasing) Vascular and non-vascular interventional procedures.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Artis Q. angiography system. Model 10848280, 10848281, 10848282, 10848283, 10848353, 10848354 & 10848355 Product Usage: Artis is a family of dedicated angiography systems developed for single and biplane diagnostic imaging and interventional procedures including, but not limited to, pediatric and obese patients. Procedures that can be performed with the Artis family include cardiac angiography, neuro angiography, general angiography, rotational angiography, operating room angiography, multipurpose angiography and whole body radiographic/fluoroscopic procedures. Artis can also support the acquisition of position triggered imaging for spatial data synthesis.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc·August 22, 2018

    Siemens Medical Solutions, ACUSON P300 Ultrasound system with P300 PA 230E cardiac probe (Esaote product 7348). Provides imaging for guidance of biopsy and imaging to assist in the placement of needles in vascular or other anatomical structures as well as peripheral nerve blocks in Musculoskeletal applications.

    FDA Enforcement
    Class II ·Terminated·Siemens Medical Solutions USA, Inc.·April 9, 2014

    MultiDiagnost Eleva w/ Flat Detector, Product codes 708034, 708037, 708038 Product Usage: As a multifunctional I universal imaging application system, General RIF, Fluoroscopy, Radiography and Angiography can be performed along with more specialized interventional applications on human patients. This includes the following general areas: Digestive system: Swallowing studies, Oesophagus, Stomach, Small intestine, Colon, Defeacography, ERCP, T-tube cholangiogram, Liver biopsies, Transjugular Intrahepatic Portosystemic Shunts (TIPS) Skeletal system: Bone studies. Urinary system: IVP, Cystograms, Percutaneous, Nephrolithotomy, Nephrostomy tube replacement Reproductive system: Hysterosalpingogram, Vena spermatica, Cavernography Respiratory system: Thorax, Bronchoscopy, Pulmonary biopsies Circulatory system: Venography, Arteriography, Thrombolytic Therapy, Em bolizations, Em bolectomy, IVC filter placement, Dilatations, Stent placement. Various: Arthrograms, Myelograms, Facet joint injections, Discography, Sialography.

    FDA Enforcement
    Class II ·Terminated·Philips North America, LLC·April 3, 2019

    Maquet PowerLED 700. Product Usage; To provide illumination to the surgical area or the patient.

    FDA Enforcement
    Class II ·Terminated·Maquet Medical Systems USA·June 18, 2014

    System Material # Artis zee floor 10094135 Artis zee ceiling 10094137 Artis zee multi-purpose 10094139 Artis zee biplane 10094141 Artis zeego 10280959 Artis Q floor 10848280 Artis Q ceiling 10848281 Artis Q biplane 10848282 Artis Q.zeego 10848283 Artis Q.zen floor 10848353 Artis Q.zen ceiling 10848354 Artis Q.zen biplane 10848355 Fluoroscopic X-Ray System

    FDA Enforcement
    Class II ·Ongoing·Siemens Medical Solutions USA, Inc·February 8, 2023

    Philips Azurion Interventional Fluoroscopic X-ray Systems, specifically the Disk Bay of the PC component of the affected system. Affected PCs: XRay PC, Suite PC, and FlexViewing PC Azurion Model Name - Model Number: Azurion 3 M12 722063 722221; Azurion 3 M15 722064 722222; Azurion 5 M20 722228; Azurion 7 B12 722067 722225; Azurion 7 B20 722068 722226; Azurion 7 M12 722078 722223; Azurion 7 M20 722079 722224;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·February 28, 2024

    Alcon Custom Ophthalmic Surgical Procedure Packs

    FDA Enforcement
    Class II ·Terminated·Alcon Research, LLC·April 7, 2021

    Azurion 7 M12; System Code: (1)722078, (2)722223, (3)722233;

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·April 8, 2026

    Philips Azurion System configured with a 1 Phase UPS. Azurion family (R1.x, R2.x). Labeled as the following with corresponding model numbers: 1. Azurion 3 M12, Model Number 722063. 2. Azurion 3 M15, Model Number 722064. 3. Azurion 7 B12, Model Number 722067. 4. Azurion 7 B20, Model Number 722068. 5. Azurion 7 M12, Model Number 722078. 6. Azurion 7 M20, Model Number 722079. 7. Azurion 3 M12, Model Number 722221. 8. Azurion 3 M15, Model Number 722222. 9. Azurion 7 M12, Model Number 722223. 10. Azurion 7 M20, Model Number 722224. 11. Azurion 7 B12, Model Number 722225. 12. Azurion 7 B20, Model Number 722226. 13. Azurion 5 M12, Model Number 722227. 14. Azurion 5 M20, Model Number 722228. 15. Azurion 7 M20, Model Number 722282.

    FDA Enforcement
    Class II ·Ongoing·PHILIPS MEDICAL SYSTEMS NEDERLAND B.V.·September 10, 2025