13 results
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78ms
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Sources: EU EUDAMED, US FDA
RIOMAVIX LTD
Authorized representative
🇪🇸 Spain·400 Manufacturers·4531 Devices
Humiss Beratung GmbH
Authorized representative
🇩🇪 Germany·152 Manufacturers·925 Devices
Lotus NL B.V.
Authorized representative
🇳🇱 Netherlands·584 Manufacturers·21427 Devices
CARESTREAM Image Suite V4; Image Suite V4: DICOM STORE SCP: REF/Catalog # 1056191, DICOM STORE SCP/FOR IMAGE SUITE V4: REF/Catalog # 6566988; Image Suite V4 Bundles: IMAGESUITE STANDALONE PACS: REF/Catalog # 1741289, IMAGESUITE STANDALONE PACS FOR INDIA: REF/Catalog # 1741297; Carestream PRO (Image Suite V4): PRO Medical Wireless GOS System-Desktop: REF/Catalog # 1741891, PRO Wireless System Laptop: REF/Catalog # 1741925, PRO Wireless System - w/o Computer: REF/Catalog # 1741933, PRO Tethered System Desktop: REF/Catalog # 1741941, PRO Tethered System Laptop: REF/Catalog # 1741958, PRO Tether System - w/o Computer: REF/Catalog # 1741966, PRO Fixed System - w/o Computer: REF/Catalog # 1741974, PRO Medical Wireless CsI System-Desktop: REF/Catalog # 1741982, PRO Wireless System Laptop: REF/Catalog # 1742006, PRO Wireless System - w/o Computer: REF/Catalog # 1742014, PRO Tethered System Desktop: REF/Catalog # 1742022, PRO Tethered System Laptop: REF/Catalog # 1742055, PRO Tether System - w/o Computer: Catalog # 1742063; PRO Fixed System - w/o Computer: REF/Catalog # 1742089 -- Made in U.S.A. by: Carestream Health, Inc., 150 Verona Street, Rochester, NY 14608 --- CLASSIFICATION NAME: System, Image Processing, Radiological The Carestream Image Suite System is an image management system whose intended use is to receive, process, review, display, print and archive images and data from CR and DR modalities. This excludes mammography applications in the United States
FDA Enforcement
Class II
·Terminated·Carestream Health Inc·May 11, 2016
Vertical Brake Hubs of the Computed Tomography X-Ray Systems under the following Brands and Model #s: Brilliance 6, M/Ns 3001-3708, 30001-30131; Brilliance 10, M/Ns 4001-4067, 40001-40035 ; Brilliance 16, M/Ns 5001-6180, 50002-50139 ; Brilliance 16P, M/Ns 6007-6163, 60001-60029 ; Brilliance 40, M/Ns 9009-9272, 29001-29153, 90028-92034; Brilliance 64, M/Ns 9501-10300, 95003-95697; Brilliance Big Bore, M/Ns 7001-7520; Brilliance iCT, M/Ns 100003-100169 & Brilliance iCT SP, M/Ns 200004-200034. The Brilliance Computed Tomography X-Ray Systems 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.
FDA Recall
Terminated
·Philips Medical Systems (Cleveland) Inc·Product code KPS·December 10, 2010
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number: 2170-3003A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 3, 2011
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 4535-602-79811; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 3, 2011
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/8", Model Number: 2170-3002A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 3, 2011
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 2170-3000A; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code -KPS·June 3, 2011
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-FIXED, 3/8", Model Number: 4535-602-79781; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 3, 2011
Philips brand BrightView Gamma Camera System, SYST, BRIGHTVIEW-TILT, 3/4", Model Number; 4535-602-79801; Product is manufactured and distributed by Philips Medical Systems (Cleveland), Inc., Cleveland, OH The BrightView Gamma Camera System is intended to produce images depicting the anatomical distributions of single photon emitting radioisotopes within the human body for interpretation by medical personnel.
FDA Recall
Terminated
·Philips Medical Systems·Product code KPS·June 3, 2011
Emergo Europe B.V.
Authorized representative
🇳🇱 Netherlands·900 Manufacturers·22100 Devices
Share info GmbH
Authorized representative
🇩🇪 Germany·154 Manufacturers·1206 Devices