# K031815: Intera-Sensation Family

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems
- Decided: Sep 10, 2003 after 90 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
67 later devices descend from it; 2 cite it directly.
5 of 68 devices 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 INTERA family release 10-series: named in the summary without a submission number

## Most influential descendants
- K043147: Achieva Family (2005), 65 descendants of its own
- K041602: Panorama 1.0T (2004), 58 descendants of its own
- 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

## Recalls of this device
- May 12, 2009 · Not classified · Z-0794-2011: The Accessory Cart contained magnetic material and is attracted to the magnet when bringing it close to the system.
- May 1, 2009 · Not classified · Z-0469-2011: Combined use of the Synergy Flex-M / Shoulder Coil 1.5T increases the chance of RF interaction and heating up of the coil. This may result in possible burns of the patient.
- Apr 30, 2007 · Not classified · Z-0983-2007: Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

## Indications for use
The indication for use for the INTERA SENSATION Release 1-series remains the same as the previous released predicate device(s), i.e. the capability as a diagnostic device that produces transverse, sagittal, coronal and oblique cross-sectional images based upon 'H metabolites, and that 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/K031815
Methodology: https://510kreport.com/methodology