# K043147: Achieva Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Feb 15, 2005 after 92 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 13 (3 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K031815 (2003). 1 ancestor in all.
65 later devices descend from it; 6 cite it directly.
4 of 67 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031815: Intera-Sensation Family, Philips Medical Systems (2003) Summary page 1.

## Most influential descendants
- K052078: Achieva, Intera and Panorama 1.0 Release 2-Series (2005), 57 descendants of its own
- 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

## Recalls of this device
- Jun 5, 2024 · Class I · Z-2165-2024: Potential for coils to heat up and harm patients (burn).
- Jun 5, 2024 · Class I · Z-2163-2024: Potential for coils to heat up and harm patients (burn).
- Jun 5, 2024 · Class I · Z-2164-2024: Potential for coils to heat up and harm patients (burn).
- Dec 21, 2018 · Class II · Z-0893-2019: 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-0905-2019: 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-0907-2019: 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-0913-2019: 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-0914-2019: 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-0884-2019: 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-0897-2019: 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-0927-2019: 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-0928-2019: 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-0906-2019: 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.

## Indications for use
ACHIEVA family consists of 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/K043147
Methodology: https://510kreport.com/methodology