10 results
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29ms
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Sources: EU EUDAMED, US FDA
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Classification: Class Ii
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SIEMENS brand ARTISTE syngo RT Therapist (RTT) version 4.3, ARTISTE Model, Part No. 08162815, Digital linear accelerators, MOSAIQ OIS system, Distributed by SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Manufactured by SIEMENS AG, MEDICAL SOLUTIONS, GERMANY.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·March 13, 2013
SIEMENS brand COHERENCE RT Therapist versions RTT MR1.5, RTT 2.1/2.1A and RTT 2.2/ 2.2B; Software release for COHERENCE Therapist 2.3 for Primus and Oncor Linear Accelerators; Model: COHERENCE AG TH, Part No. 5863506, Current R630; Product Usage: The intended use of the SIEMENS branded ONCOR and PRIMUS family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·April 10, 2013
SIEMENS brand ONCOR series Linear Accelerator Linac systems with component: any photon unflat beam option(Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013
SIEMENS brand ARTISTE Linear Accelerator Linac systems with component: any photon unflat beam option (Multiple X feature) in combination with the IMRT or mARC option. A family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer. The ARTISTE/ONCOR systems are manufactured by: SIEMENS AG, MEDICAL SOLUTIONS, GERMANY and distributed SIEMENS Healthcare IM CR RO, CR Radiation Oncology, Martinez, CA
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 11, 2013
PRIMUS, ONCOR, ARTISTE Linac systems with component 550 TxT Treatment Table. TT-A, TT-D, TT-M or TT-S Table tops. Manufactured by: SIEMENS AG, MEDICAL SOLUTIONS Roentgenstrasse 19-21 Kemnath, GERMANY 95478 The intended use of the SIEMENS branded, ARTISTE", ONCOR" and PRIMUS" family of linear accelerator systems is to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·January 29, 2014
ARTISTE or ONCOR Digital Linear Accelerators with syngo RT Therapist version 4.2/MOSAIQ OIS Systems and Multiple-X, Manufactured by SIEMENS AG. The ARTISTE and ONCOR family of Linear Accelerators are used to deliver X-ray photon and electron radiation for the therapeutic treatment of cancer.
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·August 1, 2012
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.
FDA Enforcement
Class II
·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024
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.
FDA Enforcement
Class II
·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024
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.
FDA Enforcement
Class II
·Ongoing·Siemens AG/Siemens Healthcare GmbH·July 10, 2024
MAVIG PORTEGRA 2 system operated in conjuction with a Siemens AX system Ceiling mounted surgical light
FDA Enforcement
Class II
·Terminated·Siemens Medical Solutions USA, Inc·December 19, 2012