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The MAGNETOM ESSENZA with syngo MR E11Q is indicated for use as magnetic resonance diagnostic devices (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images, spectroscopic images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities. Depending on the region of interest, contrast agents may be used. These images and/or spectra when interpreted by a trained physician vield information that may assist in diagnosis.

The MAGNETOM ESSENZA may also be used for imaging during interventional procedures when performed with MR compatible devices such as, in room display and MR-safe biopsy needles.

The subject device, MAGNETOM ESSENZA with software syngo MR E11Q, is the latest software version for the Siemens MR MAGNETOM ESSENZA. It is modified based on the software version syngo MR E11A, which was cleared with K141977 on November 19, 2014. The software functionality and applications are based on syngo MR E11A SW and have been migrated from this previously cleared software. Only minor adaptations were needed to support the system specific hardware and to optimize the sequence/protocols, also to support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).

Listed below are the hardware updates to the MAGNETOM ESSENZA system with software syngo MR E11Q:

• a modified MARS(Measurement and Reconstruction System), which is the same . as the MaRS of MAGNETOM Amira system with software syngo MR E11N (K152283, cleared on December 24, 2015)
• . an updated MRAWP (MR Syngo Acquisition Workplace), which is the same as the host platform of reference device MAGNETOM Amira with syngo MR E11N (K152283, cleared on December 24, 2015)
• . a successor EOSC (Electrical Optical Signal Converter) of original COB (CAN Open Bridge)

The MAGNETOM ESSENZA with software version syngo MR E11Q will be offered exfactory (new production) as well as in-field upgrades for the currently installed MAGNETOM ESSENZA systems.

A summary of the software feature updates to the MAGNETOM ESSENZA system with software synqo MR E11Q is provided below. All migrated features listed below have been cleared previously with K141977, K151579, and K152283.

The provided document describes the Siemens MAGNETOM ESSENZA with syngo MR E11Q, a magnetic resonance diagnostic device. The submission focuses on demonstrating substantial equivalence to previously cleared devices rather than presenting a novel device with performance metrics against a defined acceptance criterion.

Therefore, the document does not contain information related to acceptance criteria, device performance, sample size for test sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, or ground truth for training sets.

Instead, the submission details:

• Device Name: MAGNETOM ESSENZA with syngo MR E11Q
• Intended Use/Indications for Use: To produce transverse, sagittal, coronal and oblique cross-sectional images, spectroscopic images and/or spectra that display the internal structure and/or function of the head, body, or extremities. These images and/or spectra, when interpreted by a trained physician, assist in diagnosis. It may also be used for imaging during interventional procedures with MR compatible devices.
• Device Description: The latest software version for the Siemens MR MAGNETOM ESSENZA, modified from syngo MR E11A (cleared with K141977). Adaptations support system-specific hardware, optimize sequence/protocols, and support the DGSU (Digital Gradient Small signal Unit) option for GPA (Gradient Power Amplifier).
• Hardware Updates: Modified MARS (Measurement and Reconstruction System), updated MRAWP (MR Syngo Acquisition Workplace), and a successor EOSC (Electrical Optical Signal Converter).
• Migrated Software Features (previously cleared with K141977, K151579, and K152283): MyoMaps, Quiet Suite, 10-min Exam Dot Engine, Spine Dot Engine, Breast Dot Engine, Large Joint Dot Engine, Neuro fMRI Package, DTI Package, Neuro Perfusion Package, FREEZEit Body MRI Package, LiverLab, BOLD 3D Evaluation, DTI Evaluation.
• Technological Characteristics: Substantially equivalent to predicate MAGNETOM ESSENZA with syngo MR D14 regarding MR image acquisition steps/features, operational environment, programming language, operating system, and performance. Both conform to IEC 62304:2006, IEC, and NEMA standards.
• Nonclinical Tests:
  • Description: All software features were verified and validated to perform as intended. Updated hardware (MaRS, MRAWP, EOSC) was tested in system and integration tests. All functionality and performance were tested in system and integration tests.
  • Results: Tests demonstrated the device performs as intended and is substantially equivalent to predicate devices.
• Clinical Tests: None were conducted.
• Safety and Effectiveness: Labeling contains instructions, cautions, and warnings. Risk management is ensured via ISO 14971:2007 risk analysis. Adheres to IEC 60601-1 series to minimize electrical and mechanical risk. Conforms to applicable FDA recognized and international IEC, ISO, and NEMA standards.
• Predicate Devices:
  • Primary: MAGNETOM ESSENZA with syngo MR D14 (K130262, cleared March 1, 2013)
  • Secondary: MAGNETOM Aera with syngo MR E11A (K141977, cleared November 19, 2014)
• Reference Devices:
  • MAGNETOM Amira with syngo MR E11N (K152283, cleared December 24, 2015)
  • MAGNETOM Aera with syngo MR E11B (K151579, cleared September 29, 2015)
• Conclusion: The device is substantially equivalent as there are no changes to the Indications for Use compared to the primary predicate, and the new software features/capabilities are already cleared with the secondary predicate. The different technological characteristics do not raise new questions of safety and effectiveness as all features have been tested and verified/validated.

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