# K070528: Philips Essenta DR

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems GmbH, Dmc
- Decided: Mar 9, 2007 after 14 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: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K133496: X Twin System (2014), 0 descendants of its own

## Recalls of this device
- Dec 5, 2013 · Class II · Z-0584-2014: X-ray system C-arm casting may loosen and fall
- Jul 25, 2012 · Class II · Z-2207-2012: Essenta DR C-Arm may fall
- Aug 15, 2008 · Not classified · Z-0012-2011: When a patient is selected in the patient list and examination tab pressed with background query running at the same time, the wrong patient may be selected.
- Apr 8, 2008 · Not classified · Z-1895-2008: Bright artifacts may appear on a patient image from a previous exposure, which might lead to a misdiagnosis.

## Indications for use
The Essenta DR is a digital multifunctional X-ray system, suitable for all routine radiographic exams, including specialist areas like trauma or pediatric work, excluding mammography. It is designed for radiographic examination of the standing or seated patient or the recumbent patient in combination with a mobile x-ray table (trolley). The system is intended for direct digital imaging using the built in flat panel detector and in addition for free exposures on radiographic cassettes.

Source page: https://510kreport.com/device/K070528
Methodology: https://510kreport.com/methodology