# K013344: Intera I/T

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Dec 11, 2001 after 63 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K001796 (2000). 1 ancestor in all.
54 later devices descend from it; 1 cites it directly.
1 of 56 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001796: Gyroscan Intera (R7.5), Philips Medical Systems North America, Inc. (2000) 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
- Dec 21, 2018 · Class II · Z-0885-2019: 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.
- 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
INTERA I/T is a whole body 1.5T Magnetic Resonance Diagnostic Device being extended with optional hardware extensions to aid in the performance of interventional procedures in the head, body and extremities, which may be facilitated by MR techniques, such as real time imaging.

Source page: https://510kreport.com/device/K013344
Methodology: https://510kreport.com/methodology