# K052013: Achieva 1.5T & Inera 1.5T Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems Nederland B.V.
- Decided: Aug 2, 2005 after 7 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 27 (3 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). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
2 of 7 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.

## Most influential descendants
- K080048: MSK Extreme MR Scanner, Model AA5000 (2008), 2 descendants of its own
- K103238: 1.5T Optima MR430S (2011), 1 descendant of its own
- K131896: Supervan 1.5T Magnetic Resonance Imaging System (2014), 0 descendants of its own
- K123068: Optima MR 430S (2012), 0 descendants of its own

## Recalls of this device
- 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
- 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).
- 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-0889-2019: 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-0890-2019: 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-0892-2019: 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-0894-2019: 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-0896-2019: 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-0909-2019: 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-0887-2019: 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-0888-2019: 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-0891-2019: 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-0895-2019: 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-0899-2019: 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-0915-2019: 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-0908-2019: 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-0912-2019: 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.
- Mar 16, 2018 · Class II · Z-1435-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Mar 16, 2018 · Class II · Z-1433-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Sep 30, 2008 · Not classified · Z-2461-2010: The cables of the coil may become too hot and cause burns when placed too close to the patient. While using the 1.5T Sense XL Torso coil, unwanted radiofrequencies (RF) interaction with the patient ca

## Indications for use
ACHIEVA 1.5 & INTERA 1.ST 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/K052013
Methodology: https://510kreport.com/methodology