# K001796: Gyroscan Intera (R7.5)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Sep 6, 2000 after 84 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
61 later devices descend from it; 3 cite it directly.
1 of 62 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K013344: Intera I/T (2001), 54 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
- 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 
- 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-0982-2007: Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.
- Aug 20, 2004 · Not classified · Z-1488-04: Potential for patient burn

Source page: https://510kreport.com/device/K001796
Methodology: https://510kreport.com/methodology