# K971884: Asset Apollo

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 20, 1997 after 90 days
- Product code: LNH (System, Nuclear Magnetic Resonance Imaging)
- Device class: 2
- Regulation: 21 CFR 892.1000
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931544 (1993). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K933835: 0.5T Asset System, Philips Medical Systems (Cleveland), Inc. (1993) Summary page 2.
- K964626: Edge/Vista System Enhancement Package, Philips Medical Systems (Cleveland), Inc. (1997) Summary page 2.

## Recalls of this device
- Aug 7, 2013 · Class II · Z-0033-2014: There is a potential for water to collect in the vent pipe elbow in the magnet venting system. Water may freeze, blocking the venting system.

## Indications for use
The ASSET APOLLO does not change the existing intended use and indications for the ASSET system as defined below. The Picker International ASSET system is intended 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/K971884
Methodology: https://510kreport.com/methodology