# K940534: Gyroscan T10-NT (Release 4 Series Software)

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems, Inc.
- Decided: Nov 22, 1994 after 288 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
52 later devices descend from it; 1 cites it directly.
0 of 53 devices 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.

## Most influential descendants
- K963262: Artoscan M (1997), 51 descendants of its own
- K981358: Artoscan S (1998), 50 descendants of its own
- K990968: E-SCAN (1999), 49 descendants of its own
- K020164: E-Scan XQ (2002), 48 descendants of its own
- K032121: Modification to E-Scan XQ (2003), 47 descendants of its own

## Recalls of this device
- Dec 9, 2005 · Not classified · Z-0358-06: The Gyroscan NT MRI system has a computer software problem which results in images from one patient being placed into another patient's image record.

Source page: https://510kreport.com/device/K940534
Methodology: https://510kreport.com/methodology