# K030520: Intera Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Mar 6, 2003 after 15 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 12 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Gyroscan / NT INTERA family: named in the summary without a submission number

## 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
- Dec 21, 2018 · Class II · Z-0881-2019: 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-0879-2019: 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-0877-2019: 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-0878-2019: 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-0880-2019: 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-0874-2019: 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-0883-2019: 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-0886-2019: 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-1431-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Mar 16, 2018 · Class II · Z-1432-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Jul 6, 2015 · Class II · Z-1024-2016: Wrong positioning of the coil cables can create unintended resonances via the patient or elevated coil cable temperature due to coupling to the QBC. The combined use of the Sense coil, high SAR level 

## Indications for use
The INTERA Family magnetic resonance diagnostic devices produce transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and displays 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/K030520
Methodology: https://510kreport.com/methodology