# K090625: Wireless Portable Detector FD-W17

- Pathway: 510(k) (Traditional)
- Applicant: Philips Medical Systems North America Co.
- Decided: Mar 24, 2009 after 15 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: 28 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K931071 (1994). 4 ancestors in all.
41 later devices descend from it; 7 cite it directly.
0 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K982795: Philips Bucky Vision, Philips Medical Systems, Inc. (1998) Summary page 2.

## Most influential descendants
- K112132: Krystalrad 660 Digital Radiographic Portable Retrofit System (2011), 14 descendants of its own
- K130883: Sedecal Digital Radiographic Upgrade Model Sdru-T (2013), 11 descendants of its own
- K140825: Delworks DR System (2014), 7 descendants of its own
- K162529: DigiX FDX (2017), 6 descendants of its own
- K141736: Philips Prograde; Philips Eleva Workspot for Digital Diagnost (2014), 6 descendants of its own

## Recalls of this device
- Jun 27, 2018 · Class II · Z-2851-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2867-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2849-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2843-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2847-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2863-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2858-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2861-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2866-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2846-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2859-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2860-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2855-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2848-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2857-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2868-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2842-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2852-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2841-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2856-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2862-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2865-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2850-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2844-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2845-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2853-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2864-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.
- Jun 27, 2018 · Class II · Z-2854-2018: The hook does not securely hold the footplate in the vertical position. Therefore, the footplate can fall or swing down and injury operator or patient.

## Indications for use
As a part of a radiographic system, the Wireless Portable Detector FD-W17 is intended to acquire digital radiographic images. The Wireless Portable Detector FD-W17 is suitable for all routine radiography exams, including specialist areas like intensive care, trauma, or pediatric work, excluding fluoroscopy, angiography and mammography.

Source page: https://510kreport.com/device/K090625
Methodology: https://510kreport.com/methodology