# K103448: Brivo XR385

- Pathway: 510(k) (Traditional)
- Applicant: Ge Medical Systems, LLC
- Decided: Aug 12, 2011 after 261 days
- Product code: KPR (System, X-Ray, Stationary)
- 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: 4 generations back to K981556 (1998). 9 ancestors in all.
4 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)
- K982955: Silhouette VR, GE Medical Systems (1998) Summary page 2.
- K041922: GE Tethered Portable Digital Radiographic Detector, General Electric Co. (2004) Summary page 2.
- K031447: Canon, Digital Radiography, Model Cxdi-50G, Canon, Inc. (2003) Summary page 2.

## Most influential descendants
- K141381: Duradiagnost (2014), 3 descendants of its own
- K163410: DigitalDiagnost C50 (2017), 1 descendant of its own
- K201725: DigitalDiagnost C50 (2020), 0 descendants of its own
- K201640: DuraDiagnost (2020), 0 descendants of its own

## Recalls of this device
- Sep 16, 2016 · Class II · Z-2523-2018: The placing of weight on the VRAD detector, of the Brivo XR385 digital radiographic system, can introduce image artifacts, which can result in patient exam retakes.

## Indications for use
The Brivo XR385 Digital X-Ray System is intended for use on both adult and pediatric subjects for taking diagnostic radiographic exposures of the skull, spinal column, chest, abdomen, extremities, and other body parts. Applications can be performed with the patent sitting, standing, or lying in the prone or supine position. This device is not intended for mammographic applications.

Source page: https://510kreport.com/device/K103448
Methodology: https://510kreport.com/methodology