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The MAGNETOM systems are indicated for use as a magnetic resonance diagnostic device (MRDD) that produces transverse, sagittal, coronal and oblique cross sectional images and/or spectra, and that displays the internal structure and/or function of the head, body, or extremities.

Other physical parameters derived from the images and/or spectra may also be produced. Depending on the region of interest, contrast agents may be used. These mages and the physical parameters derived from the images and/or spectra, when interpreted by a trained physician, yield information that may assist in diagnosis.

The MAGNETOM systems 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.

MAGNETOM Aera, MAGNETOM Skyra and MAGNETOM Prisma/Prisma" with syngo MR E11C software were cleared with K153343 and MAGNETOM Avanto" and MAGNETOM Skyrafff systems with syngo MR E11C software were cleared with K162102.

To address the new feature GOKnee3D and the modifications summarized in Section 3 and furthermore described in this Premarket Notification Siemens intends to make the software application package syngo MR E11C - AP04 available to the systems mentioned above.

The additional options for the synqo MR E11C software is being made available for the following MAGNETOM MR Systems:

• . MAGNETOM Aera,
• MAGNETOM Skyra / Skyraf" ●
• MAGNETOM Prisma / Prisma™ ●
• MAGNETOM Avantofit .

Those options include a new feature with a modified sequence and modified features for the above mentioned MR systems. A high level summary of sequences, features and improvements made available for the above systems is included below.

The provided text does not contain information about specific acceptance criteria, a study proving a device meets these criteria, or detailed performance metrics. The document is a 510(k) premarket notification summary for Siemens MAGNETOM MRI systems, explaining their substantial equivalence to previously cleared devices.

It discusses:

• Device Name: MAGNETOM Aera, MAGNETOM Skyra/Skyrafit, MAGNETOM Prisma/Prismafit, MAGNETOM Avantofit with syngo MR E11C - AP04 software.
• Intended Use: Magnetic resonance diagnostic device (MRDD) for imaging internal structures and functions of the head, body, or extremities, assisting in diagnosis.
• New Feature: GOKnee3D (fast, push-button knee examination with AutoAlign knee localizer and two CAIPIRINHA SPACE sequences).
• Modified Features: SPACE with CAIPIRINHA acquisition technique, Dual Monitor support, Compressed Sensing Cardiac Cine (BEAT_CS Sequence).
• Technological Characteristics: Similar to predicate devices, conforming to IEC 62304:2006 and other standards.
• Nonclinical Tests: Performance testing for modified sequence (CAIPIRINHA SPACE), image quality assessments of new sequences/algorithms, software verification and validation.
• Clinical Tests: "No clinical tests were conducted to support the subject devices and the substantial equivalence argument; however, clinical images and LV evaluation were provided to support the argumentation and documentation which demonstrate the clinical utility and technical capabilities of the method."
• Safety and Effectiveness: Risk management via ISO 14971:2007, adherence to IEC 60601-1 series, and compliance with FDA recognized standards.
• Substantial Equivalence: Concluded based on identical intended use and similar technological characteristics to predicate devices. The hardware is unchanged.

Therefore, I cannot populate the requested table or answer the specific questions about acceptance criteria, study details, sample sizes, expert involvement, and ground truth establishment, as this information is not present in the provided text. The document explicitly states that no clinical tests were conducted, and the assessment relies on nonclinical tests and substantial equivalence to predicate devices.

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