# K110151: Achieva R4 1.5T and Achieva R4 3.0T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Health Care
- Decided: Mar 22, 2011 after 63 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 20 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K031815 (2003). 7 ancestors in all.
34 later devices descend from it; 8 cite it directly.
4 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063559: Achieva, Intera and Panorama 1.0T, Release 2.5, Philips Medical Systems (2007) Summary page 1.
- K043147: Achieva Family, Philips Medical Systems North America Co. (2005) Summary page 1.

## Most influential descendants
- K163116: Ingenia 1.5T, Ingenia 1.5T S and Ingenia 3.0T R5.3 (2017), 19 descendants of its own
- K173079: Ingenia 1.5T, Ingenia 1 5T S, Ingenia 1.5T CX, Ingenia 3.0T CX R5.4 (2018), 15 descendants of its own
- K183063: Ingenia, Ingenia CX, Ingenia Elition, and Ingenia Ambition MR Systems (2019), 13 descendants of its own
- K143606: MultiBand SENSE (2015), 13 descendants of its own
- K162940: MultiBand SENSE (2016), 12 descendants of its own

## Recalls of this device
- Aug 28, 2026 · Class II · Z-3314-2026: When exporting diffusion tensor imaging (DTI) scans from a MR system using the Enhanced MR DICOM format, the exports contain incorrect data (diffusion directions). If the Enhanced MR DICOM export is u
- Aug 21, 2026 · Class II · Z-3243-2026: A software issue will terminate an examination during the image reconstruction process if the scan parameters are manually adjusted such that reconstruction requirements exceed the available system me
- Aug 11, 2021 · Class II · Z-2411-2021: When using manual mode, the tabletop may not completely move in or out and result in potential delay in patient evacuation from the bore, which could result in a delay of treatment
- Jul 30, 2021 · Class II · Z-2346-2021: Pressure relief valve 42 psi installed in the magnet assembly instead of a 3.75 psi valve, may result in release of helium gas and cause injury
- Dec 21, 2018 · Class II · Z-0924-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 21, 2018 · Class II · Z-0926-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 21, 2018 · Class II · Z-0925-2019: There is a potential for the ceiling speaker(s) to fall from their position and be pulled to the MR system by the magnetic field.
- Dec 1, 2016 · Class II · Z-0825-2017: Possibility that a patient or user may be exposed to a very small level of touch current.
- Aug 21, 2014 · Class II · Z-0325-2016: When a fused series of a sagittal, coronal or radial multi station scan is generated in MobiView, the resultant image order is reversed. This occurs with software release R5.1.7/R5.1.8.
- Jul 27, 2014 · Class II · Z-2237-2014: The following software issues have been identified in the affected products. Problem 1: When reopening a bookmark generated from processing a MUGA (Multi-Gated Acquisition) scan within the NM Cardiac 
- Jun 13, 2014 · Class II · Z-1865-2014: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
- Jun 13, 2014 · Class II · Z-1862-2014: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
- Jun 13, 2014 · Class II · Z-1864-2014: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
- Jun 13, 2014 · Class II · Z-1863-2014: For some identified Ingenia systems shipped between December 2013 and March 2014, cover set rear magnetic M10 nuts were erroneously supplied instead of A4 stainless steel nuts.
- May 15, 2014 · Class II · Z-1827-2014: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
- May 15, 2014 · Class II · Z-1826-2014: Ingenia customers have experienced clamping of the foot under the central column of the Height Adjustable Flex Trak trolley and the Trolley Variable Height IRF.
- May 5, 2014 · Class II · Z-0135-2016: In spine clinical workflows, cross reference lines may be used to determine the position of slices. In cases, where MobiView fused Images are used to show the cross reference lines, the cross referenc
- Mar 11, 2014 · Class II · Z-1678-2014: During SPECT reconstructions using Attenuation Correction and Scatter Correction, no Scatter Correction is being applied in the AutoSPECT Pro application on IntelliSpace Portal. In addition, resolutio
- Jan 27, 2012 · Not classified · Z-1125-2012: There maybe incorrect values in the diffusion/perfusion maps.
- Aug 3, 2011 · Not classified · Z-0293-2012: The firm determined that during scanning procedures, for some larger patients, some reddening of the skin of can occur in certain instances due to RF heating when the torso of the patient is positione

## Indications for use
The ACHIEVA R4 1.5T and ACHIEVA R14 3.OT are magnetic resonance diagnostic devices that produce cross-sectional images, spectroscopy images and/or spectra in any orientation of the internal structure of the whole body. These images when interpreted by a trained physician, yield information that may assist in diagnosis. In addition, the ACHIEVA R4 1.5T and ACHIEVA R4 3.OT devices provide capabilities to perform interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging. Such procedures must be performed with MR compatible instrumentation as selected and evaluated by the clinical user.

Source page: https://510kreport.com/device/K110151
Methodology: https://510kreport.com/methodology