# K992467: Imagclear Mammography Review System

- Pathway: 510(k) (Traditional)
- Applicant: Dba Systems, Inc.
- Decided: Feb 10, 2000 after 202 days
- Product code: LMA (Digitizer, Image, Radiological)
- Device class: 2
- Regulation: 21 CFR 892.2030
- 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 K932760 (1994). 2 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K932760: DFS-2100, Dba Systems, Inc. (1994) Summary page 1.
- K946334: GALEN, Medimage, Inc. (1995) Summary page 1.

## Most influential descendants
- K031132: Consultiva Case Input Station, Model Cis-1 (2003), 1 descendant of its own
- K061160: M-VU Cad Station (2006), 0 descendants of its own

## Indications for use
The ImagClear® Mammography Review System is intended to digitize analog medical images, which will be viewed, archived, or electronically shared with other health care professionals. The ImagClear® System is specifically indicated for the digitization of mammographic images for review and analysis, but not as the sole basis for screening or diagnosis.

Source page: https://510kreport.com/device/K992467
Methodology: https://510kreport.com/methodology