# K945155: AIRIS

- Pathway: 510(k) (Traditional)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: May 24, 1995 after 215 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.
51 later devices descend from it; 1 cites it directly.
0 of 52 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
- 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
- K042236: G-SCAN (2004), 45 descendants of its own

## Recalls of this device
- Aug 16, 2006 · Not classified · Z-0029-2007: Image orientation error. When a 3D Maximum Intensity Projection (MIP) image data set is transferred from the MRI system to a computer workstation via the DICOM protocol, the anatomical markers do not 
- Mar 17, 2006 · Not classified · Z-1105-06: Software anomaly. A software defect in the referenced systems can cause a slice indicator (reference line) to be mis-positioned on the cross-reference image when it is magnified. This image error coul
- Dec 1, 2005 · Not classified · Z-0428-06: The bolts holding the lift mechanism may be damaged causing them to fail and the table top to drop several inches.

Source page: https://510kreport.com/device/K945155
Methodology: https://510kreport.com/methodology