# K102615: Wireless DR Imaging Option-WDR1

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Nov 18, 2010 after 70 days
- Product code: MQB (Solid State X-Ray Imager (Flat Panel/Digital Imager))
- Device class: 2
- Regulation: 21 CFR 892.1680
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931071 (1994). 7 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982196: Digital Radiographic Imaging System, GE Medical Systems (1998) Summary page 1.
- K090625: Wireless Portable Detector FD-W17, Philips Medical Systems North America Co. (2009) Summary page 2.

## Most influential descendants
- K103476: BRIVOXR285AMX, Optima XR200AMX, OPTIMAXR220AMX (2011), 5 descendants of its own
- K142383: Optima XR200amx, Optima XR220amx (2014), 4 descendants of its own
- K162990: Optima XR240amx (2016), 3 descendants of its own
- K173602: Optima XR240amx, AutoGrid (2018), 2 descendants of its own
- K182234: Optima XR240amx (2018), 1 descendant of its own

## Recalls of this device
- Jan 20, 2014 · Class II · Z-1078-2014: GE Healthcare has recently become aware of a software issue associated with patient selection from the worklist on your WDR1(Precision 500D and Proteus XR/a equipped with Wireless Digital Radiography 

## Indications for use
The Wireless DR Imaging Option -WDRI, when used with a radiographic imaging system, is indicated for use in generating radiographic images of human anatomy. It is intended for use in all routine radiography exams, and specialized areas including pediatric work, intensive care and trauma, wherever conventional screen-film systems or CR systems maybe used. The device is not intended for mammography or fluoroscopy applications.

Source page: https://510kreport.com/device/K102615
Methodology: https://510kreport.com/methodology