MRI Modules

IMAnalytics V2.0

Fully automated Tier 3 analysis of radio frequency (RF)-induced local power deposition at the electrodes of implantable devices for millions of excitations. IMAnalytics and MRIxViP are qualified by the FDA for MRI safety evaluations.

IMA med

IMAnalytics Module: automated Tier 3 analysis of implants (PiX transfer functions) with user-defined parameter ranges (e.g., normalizations, coil dimensions, shimming angles, clinical routings, subsets of the patient population and landmarks).

Product description

IMAnalytics is a novel software platform solution for the comprehensive safety evaluation of implantable devices. The module is designed to characterize the RF-induced heating at the distal electrodes of implantable devices, using a variant of the Tier 3 approach as defined in ISO/TS 10974. It is tailored for elongated lead structures by making use of the transfer function method described in Annex K of the same technical specification.



IMAnalytics evaluation tool and the IT'IS field libraries MRIxViP1.5T/3.0T are the first FDA-approved computational modeling Medical Device Development Tool (MDDT). Report


  • Fully compatible with the exposure field libraries MRIxViP of the IT’IS Foundation.
  • Preprocessing of terabytes of electromagnetic (EM) field data from many combinations of birdcage types, anatomies, landmark positions and implant routing paths.
  • Direct input of the transfer function of the implanted device from piX system.
  • Different polarizations and exposure conditions by sweeping through many independent excitation settings of the I and Q channels.
  • Efficient evaluation of millions of exposure scenarios and extraction of relevant statistical data on deposited power.
  • Evaluation of deposited power at different operating modes (normal, first level controlled).
  • Different limits defined in terms of whole-body specific absorption rate (SAR), partial-body SAR, head SAR or B1 field values.


  • MR-safety with respect to RF-induced heating of structures such as leads for cardiac pacing/sensing, implantable cardioverter defibrillator (ICD), spinal cord stimulation (SCS), and deep-brain stimulation (DBS) systems.


Version 2.0 of IMAnalytics has been extensively tested and validated.

The verification benchmarks use as reference either analytic results from simple setups or results produced by different implementations of similar algorithms. When possible, all the verification steps are automated in such a way that they can be run for every update of the software.

Our approach combines some simplified test fixtures with realistic scenarios. In the first case, the reference results are derived analytically while in the second case they are obtained using an alternative algorithm or implementation.

Full verification and validation (v&v) documentation, including the descriptions of our test fixtures and validation criteria, is provided to all customers.

Verification Report Summary


The verification report defines six tests, their results and acceptance criteria to verify the software Module IMAnalytics. They are considered to be sufficient to determine the correctness and completeness of thesoftware module for applications in their context of use, i.e., evaluations according to Tier 3 of ISO/TS 10974.

Software Verified

The verifications have been performed for the Implant Safety Analysis Module IMAnalytics V2.0.


Description Version Test Date Test Results
1 Q-matrix V2.0 March 19, 2019 passed
2 Etan evaluation V2.0 March 19, 2019 passed
3 Mass evaluation V2.0 March 19, 2019 passed
4 End-to-end workflow V2.0 March 19, 2019 passed
5 SAR limits V2.0 March 19, 2019 passed
6 B1 limits V2.0 March 19, 2019 passed
7 Deposited Power and Induced Voltage V2.0 March 19, 2019 passed
8 Manual comparison V2.0 March 19, 2019 passed


The Implant Safety Analysis Module IMAnalytics V2.0 passed all tests and is considered error free in its contexts of use.


Histogram of Tier 3 deposited power for a given position of the anatomical models.

Selection of anatomical model and routings.

Tier 3 deposited power for different imaging positions.