# K970640: Philips Easy Diagnost

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America, Inc.
- Decided: Mar 21, 1997 after 29 days
- Product code: IXR (Table, Radiographic, Tilting)
- Device class: 2
- Regulation: 21 CFR 892.1980
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K924593 (1992). 1 ancestor in all.
7 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K924593: Diagnost 76 Family*R/F Systems - Release 4.4, Philips Medical Systems, Inc. (1992) Summary page 2.
- (no number) Diagnost 73: named in the summary without a submission number

## Most influential descendants
- K031535: Philips Easydiagnost Eleva (2003), 6 descendants of its own
- K173433: ProxiDiagnost N90 (2018), 2 descendants of its own
- K163210: Philips CombiDiagnost R90 (2017), 2 descendants of its own
- K212837: ProxiDiagnost N90 (2021), 1 descendant of its own
- K203087: CombiDiagnost R90 (2020), 1 descendant of its own

## Recalls of this device
- Jul 11, 2012 · Class II · Z-2208-2012: Inclination switch in the stand may have been mounted incorrectly, as a result, the switch could not stop the tilting movement of the table base due tol hardware or software errors.
- May 11, 2012 · Class II · Z-1821-2012: If a lead ruler is not positioned in the same plane as the anatomical image detail to be measured, measured object distances (using the ruler) can be wrong by a corresponding factor. If, additionally,
- Jan 21, 2010 · Not classified · Z-0849-2010: Device failed to display appropriate labels indicating Radiation Symbol along with the required wording.
- Jan 4, 2008 · Not classified · Z-2405-2010: Potential for the tower (holding the serial changer and/or image intensifier) to slide unexpectedly and potentially injure a patient or user in its path.
- Jul 23, 2007 · Not classified · Z-0909-2007: Units do not comply with the requirement to provide automatic beam limitation within +/- 3 degrees of horizontal, vertical, and perpendicular to the plane of the image receptor during radiographic pro

Source page: https://510kreport.com/device/K970640
Methodology: https://510kreport.com/methodology