# K962589: Aurora Diagnostic Workstation

- Pathway: 510(k) (Traditional)
- Applicant: Aurora Technology, Inc.
- Decided: Sep 20, 1996 after 80 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
No predicates in its family tree.
39 later devices descend from it; 3 cite it directly.
0 of 40 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) User retrieval and image viewing stations manufactured by Eltrax Systems, Inc. (now Emerald Archiving, Inc.): named in the summary without a submission number

## Most influential descendants
- K972701: Barco MWD 321 Medical Workstation Display (1998), 38 descendants of its own
- K980541: Barco MGD 521 5 Megapixel Diagnostic Display (1998), 33 descendants of its own
- K033859: Barcoview MGD 521M Digital Mammography Display (2004), 31 descendants of its own
- K042755: Monochrome LCD Monitor, Radiforce G51 (2005), 15 descendants of its own
- K041737: 5M Monochrome Digital Mammography LCD Monitor ME511L (MDL2105A) (2004), 14 descendants of its own

## Indications for use
The intended use of the Aurora Diagnostic Workstation is identical to other commercially available medical imaging workstations.

Source page: https://510kreport.com/device/K962589
Methodology: https://510kreport.com/methodology