# K983392: Data Ray Corporation DR11021 Medical Imaging Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Data Ray
- Decided: Dec 15, 1998 after 81 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: 4 generations back to K913770 (1991). 16 ancestors in all.
No later device cites it as a predicate yet.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980541: Barco MGD 521 5 Megapixel Diagnostic Display, Barco NV Display Systems (1998) Summary page 1.
- K972701: Barco MWD 321 Medical Workstation Display, Barco NV Display Systems (1998) Summary page 1.
- K970999: Sony PGM-100P1MD Trinitron Color Graphic Monitor, Sony Medical Systems (1997) Summary page 1.
- K962589: Aurora Diagnostic Workstation, Aurora Technology, Inc. (1996) Summary page 1.
- K961023: Aidp (Accuimage Image Display Processor), Accuimage, Inc. (1996) Summary page 1.
- K960613: GE Advantage Windows Review Workstation, GE Medical Systems (1996) Summary page 1.

## Indications for use
The Data Ray Corporation DR11021 Medical Imaging Monitor is used in filmless radiology systems to display digitized x-ray images. These digitized x-ray images are viewed by trained medical providers for the purpose of diagnosing and/or treating illnesses in human beings.

Source page: https://510kreport.com/device/K983392
Methodology: https://510kreport.com/methodology