# K983401: Framewave Web

- Pathway: 510(k) (Traditional)
- Applicant: Ml Strategies, Inc.
- Decided: Dec 15, 1998 after 78 days
- Product code: LLZ (System, Image Processing, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2050
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Recalls of this device
- Oct 28, 2011 · Class II · Z-0294-2017: After a period of time running Fusion Workstation, the Hounsfield measurement tool will report incorrect values.

## Indications for use
The Access Radlology "Framewave Web" Image and Information System is indicated for che transmission and review of radiologic images and assoclated information stored and transmitted in both compressed and uncompressed form.

Source page: https://510kreport.com/device/K983401
Methodology: https://510kreport.com/methodology