# K022390: Hitachi Altaire

- Pathway: 510(k) (Abbreviated)
- Applicant: Hitachi Medical Systems America, Inc.
- Decided: Oct 11, 2002 after 80 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
Longest line of descent: 1 generation back to K992746 (1999). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K001334: Hitachi Airis II, Hitachi Medical Systems America, Inc. (2000)
- K992746: Signa Hfo/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.

## Recalls of this device
- Feb 21, 2006 · Not classified · Z-0910-06: The device has a software anomaly which causes the operating system to 'lock up' and data to become corrupted during service procedures.
- Jan 27, 2006 · Not classified · Z-1103-06: Circuit Failure-There is the potential risk of the Phase Loss Detector Safety Device (PHSEN PCB) malfunctioning in the event of a power loss. The circuit may fail to turn off the system main breaker w
- Jun 30, 2005 · Not classified · Z-0888-05: Image reconstruction software problem that could potentially cause multiple patient images to be stored in one patient folder.
- Apr 11, 2005 · Not classified · Z-0797-05: The electrical cables that supply gradient power to the magnet can become loose over time and create a potential fire hazard.
- Nov 18, 2004 · Not classified · Z-0846-05: The absorber unit in the helium compressor which is located in equipment rooms, and is not accessed by patients or system operators, may fail under pressure, causing an explosion that damages the comp

## Indications for use
The Altaire MR system is an imaging device, and is intended to provide the physician with physiological and clinical information, obtained non-invasively and without the use of ionizing radiation. The MR system produces transverse, coronal, sagittal, oblique, and curved cross-sectional images that display the internal structure of the head, body, or extremities. The images produced by the MR system reflect the spatial distribution of protons (hydrogen nuclei) exhibiting magnetic resonance. The NMR properties that determine the image appearance are proton density, spin-lattice relaxation time (Tl), spin-spin relaxation time (E), and flow. When interpreted by a trained physician, these images provide information that can be useful in diagnosis determination.

Source page: https://510kreport.com/device/K022390
Methodology: https://510kreport.com/methodology