# K020268: Isaac 1.5 T MR System

- Pathway: 510(k) (Traditional)
- Applicant: Chi, Inc.
- Decided: Apr 25, 2002 after 90 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: 3 generations back to K893619 (1989). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K971684: Magnetom Project 047 System (Numaris 3.5 Software), Siemens Medical Solutions USA, Inc. (1997) Summary page 1.
- K971246: Leo 7000 Quadrature Knee Coil, Usa Instruments, Inc. (1997) Summary page 1.
- K010946: Mark 9000 Phased Array Shoulder Coil, Usa Instruments, Inc. (2001)
- K964531: Profile 70000 Quadrature Volume Neck Coil, Us Asia Instruments, Inc. (1997) Summary page 1.
- K972205: Alpha 7000 Quadrature Wrist Coil, Usa Instruments, Inc. (1997) Summary page 1.
- K980157: Premier 7000 CTL Spine Coil, Usa Instruments, Inc. (1998) Summary page 1.

## Cited in the summary but kept off the family tree
- K982340: Extracorporeal Blood Circuit, Haidylena Medical Egypt (1999). Our OCR of the scanned summary read K982340, FDA’s number for Extracorporeal Blood Circuit (Haidylena Medical Egypt). Its FDA name has none of the distinctive words the summary uses for the device it names, “USA Instruments specialty coil”. Kept off the family tree. Summary page 1.

## Indications for use
The ISAAC 1.5 T MR System is a 1.5 T whole-body magnetic resonance imaging (MRI) system intended for general diagnostic use. Sagittal, coronal and oblique planes may be imaged. MRI images produced by the ISAAC system reflect the spatial distribution of the density of hydrogen nuclei (protons), spin-lattice relaxation time (T1), spin-spin relaxation time (T2), and flow. When interpreted by a trained physician, these images provide information that can be useful in determining an diagnosis.

Source page: https://510kreport.com/device/K020268
Methodology: https://510kreport.com/methodology