# K945945: Gyroscan Acs-NT, Gyroscan T5-NT and Gyroscan T10-NT

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Dec 22, 1995 after 382 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 5 (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. FDA has not posted a summary or statement for it, so its predicates are not known.

## Recalls of this device
- Mar 16, 2018 · Class II · Z-1439-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Mar 16, 2018 · Class II · Z-1438-2018: Potential risk for helium gas inside the MR examination room during a magnet quench
- Mar 16, 2018 · Class II · Z-1440-2018: 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 
- Apr 30, 2007 · Not classified · Z-0981-2007: Potential for gaseous helium to improperly vent, resulting in rupture of the magnet vessel and venting of helium into the MRI site.

Source page: https://510kreport.com/device/K945945
Methodology: https://510kreport.com/methodology