# K993802: Sharpview Image Enhancement System

- Pathway: 510(k) (Traditional)
- Applicant: Context Vision AB
- Decided: Jan 18, 2000 after 70 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K922470 (1992). 1 ancestor in all.
120 later devices descend from it; 5 cite 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)
- K922470: Ies, Image Enhancement System, Open Mri, Inc. (1992) Summary page 1.

## Most influential descendants
- 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
- K142517: SoftVue (2014), 49 descendants of its own

## Indications for use
The SharpView Image Enhancement System is intended for use by a qualified/trained technologist for transfer, storage, enhancement, and viewing of MRI images.

Source page: https://510kreport.com/device/K993802
Methodology: https://510kreport.com/methodology