# K992412: Ipass Bolus Tracking

- Pathway: 510(k) (Special)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 17, 1999 after 28 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 K931544 (1993). 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)
- K964626: Edge/Vista System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.

## Indications for use
The iPass Bolus Tracking option does not change the existing intended use and indications for the Eclipse/Polaris systems as defined below. The Picker International Eclipse/Polaris systems are indicated for use as a NMR device that produces images that: (1) correspond to the distribution of protons exhibiting NMR, (2) depend upon the NMR parameters (proton density, flow velocity, spin-lattice relaxation time (T1), and spin-spin relaxation time (T2)) and (3) display the soft tissue structure of the head and whole body. When interpreted by a trained physician, these images yield information that can be useful in the determination of a diagnosis.

Source page: https://510kreport.com/device/K992412
Methodology: https://510kreport.com/methodology