# K090080: Cirrus Open

- Pathway: 510(k) (Traditional)
- Applicant: Mri-Tech Sp. Zo.O.
- Decided: Mar 23, 2009 after 70 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: 1 generation back to K974212 (1998). 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)
- K992135: Signa Profile/I Magnetic Resonance System, Ge Medical Systems, Inc. (1999) Summary page 1.
- K974212: Airis II, Hitachi Medical Systems America, Inc. (1998) Summary page 1.

## Indications for use
Cirrus Open is an open, 0.2 Tesla MR imaging device intended to provide a physician with physiological and clinical information obtained non-invasively using magnetic resonance imaging (MRI) without the use of ionizing radiation. Cirrus Open is indicated for use as a diagnostic imaging device to produce images in the transverse, sagittal, coronal and oblique scan planes of a patient's head. The images produced by Cirrus Open reflect the spatial distribution of protons (hydrogen nuclei). The magnetic properties that determine the appearance of images are proton density, spin-lattice relaxation time (T1), spin-spin relaxation time (T2) and T2* relaxation time. Additional contrasts that can be used include magnetization transfer and diffusion. When interpreted by a trained physician, these images provide information that can be useful in diagnosis.

Source page: https://510kreport.com/device/K090080
Methodology: https://510kreport.com/methodology