# K052078: Achieva, Intera and Panorama 1.0 Release 2-Series

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Sep 7, 2005 after 37 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 12 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K031815 (2003). 3 ancestors in all.
57 later devices descend from it; 2 cite it directly.
4 of 61 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.

## Most influential descendants
- K063559: Achieva, Intera and Panorama 1.0T, Release 2.5 (2007), 53 descendants of its own
- 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

## Recalls of this device
- Aug 21, 2026 · Class II · Z-3234-2026: 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 21, 2026 · Class II · Z-3240-2026: 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 21, 2026 · Class II · Z-3233-2026: 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 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
- 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.
- Dec 21, 2018 · Class II · Z-0876-2019: 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-0875-2019: 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.
- Nov 20, 2014 · Class II · Z-1307-2015: VCG battery ignited in a VCG unit when recharging.

## Indications for use
The ACHIEVA, INTERA and PANORAMA 1.OT Release 2-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.

Source page: https://510kreport.com/device/K052078
Methodology: https://510kreport.com/methodology