# K980831: Image Post-Processing Techniques

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems (Cleveland), Inc.
- Decided: Aug 27, 1998 after 176 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 K913475 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K960265: Advantage Windows with Functool Option, GE Medical Systems (1996) Summary page 2.
- K971965: Philips Easyvision, Philips Medical Systems, Inc. (1998) Summary page 2.
- K974530: Duffusion-Weighted MR Imaging Package, Philips Medical Systems (Cleveland), Inc. (1998) Summary page 2.

## Indications for use
The intended use and indications for use for each of the types of Post-Processing Techniques described in this submission are described below. ProPak Techniques The ProPak Package for Picker MR systems or workstations provide supplemental information regarding contrast changes over time for those images extracted from MR temporal datasets. The indications for use for the MR system remain unchanged. Diffusion Coefficient Mapping The Picker Diffusion-Weighted MR Imaging Package has been designed to image the diffusive mobility of water or other proton-containing molecules. One important clinical application is to visualize the apparent loss of mobility of water molecules in brain tissue affected by acute stroke. Areas of decreased diffusion, as is observed in acute cerebral infarcts, appear as areas of higher image intensity. Post-processing using ADC mapping produces parametric images with further contrast manipulation. Diffusion weighted MR pulse sequences are more accurate than conventional MRI pulse sequences in identifying the occurrence of acute stroke during the first 24 hours after onset of symptoms.

Source page: https://510kreport.com/device/K980831
Methodology: https://510kreport.com/methodology