# K922470: Ies, Image Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Open Mri, Inc.
- Decided: Nov 27, 1992 after 185 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
No predicates in its family tree.
121 later devices descend from it; 1 cites it directly.
0 of 122 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K993802: Sharpview Image Enhancement System (2000), 120 descendants of its own
- K024028: Sharp View Image Enhancement System (2003), 106 descendants of its own
- K052355: Automated Breast Ultrasound System, Model Abus (2005), 64 descendants of its own
- K080555: Sofia Automated Tomographic Ultrasound (Atus) (2008), 53 descendants of its own
- K123209: Softvue (2013), 50 descendants of its own

Source page: https://510kreport.com/device/K922470
Methodology: https://510kreport.com/methodology