# K063559: Achieva, Intera and Panorama 1.0T, Release 2.5

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Jan 4, 2007 after 38 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 10 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K031815 (2003). 6 ancestors in all.
53 later devices descend from it; 7 cite it directly.
4 of 60 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K043147: Achieva Family, Philips Medical Systems North America Co. (2005) Summary page 1.
- K041602: Panorama 1.0T, Philips Medical Systems North America, Inc. (2004) Summary page 1.
- K052078: Achieva, Intera and Panorama 1.0 Release 2-Series, Philips Medical Systems Nederland B.V. (2005) Summary page 1.
- K013344: Intera I/T, Philips Medical Systems North America Co. (2001)

## Most influential descendants
- K110151: Achieva R4 1.5T and Achieva R4 3.0T (2011), 34 descendants of its own
- 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

## Recalls of this device
- Aug 21, 2026 · Class II · Z-3232-2026: 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
- May 3, 2024 · Class II · Z-1855-2024: The g-MDU (global Mains Distribution Unit) L3 terminal connection may become loose creating a hotspot that may cause smoke/fire to alarm in the hospital's technical room, resulting in Smoke and/or fir
- Nov 17, 2023 · Class I · Z-0505-2024: Firm was informed of an event in which the structural integrity of the MR system components failed due to unintended excessive pressure buildup of helium gas during a magnet quench. If the system is u
- Oct 23, 2023 · Class II · Z-0393-2024: Potential component failure in the Gradient Coil could product smoke and/or fire.
- Oct 23, 2023 · Class II · Z-0389-2024: Potential component failure in the Gradient Coil could product smoke and/or fire.
- Oct 23, 2023 · Class II · Z-0390-2024: Potential component failure in the Gradient Coil could product smoke and/or fire.
- Oct 23, 2023 · Class II · Z-0392-2024: Potential component failure in the Gradient Coil could product smoke and/or fire.
- 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.
- 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
- Aug 13, 2008 · Not classified · Z-0971-2009: Battery Failure: The Invivo Lithium Polymer Wireless Module Battery Part Number 9065 and the Lithium Polymer Fiber Optic Module Battery Part Number 9067 is being recalled because the battery, itself, 

## Indications for use
The ACIREVA, INTERA and PANORAMA LOT Release 2.5-series 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, Intera and Panorama 1.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/K063559
Methodology: https://510kreport.com/methodology