# K082684: 4D Viewer Radiology, Model Uswp-100A

- Pathway: 510(k) (Traditional)
- Applicant: Toshiba America Medical Systems, In.C
- Decided: Oct 14, 2008 after 29 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: 10 generations back to K894632 (1989). 54 ancestors in all.
No later device cites it as a predicate yet.
0 of 55 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K081065: Aplio XG Diagnostic Ultrasound System, Model Ssa - 790A, Version 2.2, Toshiba America Medical Systems, In.C (2008) Summary page 1.

## Indications for use
When used by a qualified physician, this device is intended for displaying and analyzing ultrasound images for medical diagnosis in obstetric/gynecology and general examinations. This device is not intended for diagnosis of lossy compressed images.

Source page: https://510kreport.com/device/K082684
Methodology: https://510kreport.com/methodology