# K053309: Altaire Interventional MR Package

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Jan 24, 2006 after 57 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K955389 (1996). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K984280: Airis II Magnetic Resonance Diagnostic Device,Interventional MR Package, Hitachi Medical Systems America, Inc. (1999) Summary page 1.

## Indications for use
The Hitachi Model Altaire MR Interventional Package aids in the performance of minimally invasive, diagnostic, therapeutic, interventional and intra-operative surgical procedures for the head, body, and extremities that may be facilitated by real-time MR guidance. Such procedures must be performed with MRI-compatible instrumentation as selected and evaluated by the clinical user.

Source page: https://510kreport.com/device/K053309
Methodology: https://510kreport.com/methodology