# K103597: DX-D 100

- Pathway: 510(k) (Traditional)
- Applicant: Agfa Healthcare N.V.
- Decided: Jan 3, 2011 after 26 days
- Product code: IZL (System, X-Ray, Mobile)
- Device class: 2
- Regulation: 21 CFR 892.1720
- Recalls of this device: 6 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K981556 (1998). 30 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090322: Easy Moving Plus, SM-XXHF-YY, Sedecal., Sa. (2009) Summary page 1.
- K092669: DX-D Imaging Package, Agfa Healthcare N.V. (2009) Summary page 1.

## Most influential descendants
- K191884: DR 100s (2019), 0 descendants of its own

## Recalls of this device
- Feb 23, 2024 · Class II · Z-1462-2024: Steel cable installed inside the mobile column which supports the weight of the telescopic arm with the tube head has potential risk -an interference could cause the safety system which blocks the arm
- Jan 20, 2016 · Class II · Z-1698-2017: The DX-D100 User Manual already contained information about to move a DX-D100 mobile unit manually by using an Allen wrench, but did not indicate where the Allen wrench should be stored.
- May 29, 2015 · Class II · Z-1745-2015: When using the DX-D 100 unit, sporadic unintended movements caused by an electrostatic discharge of the unit to the ground may occur.
- Jun 6, 2014 · Class II · Z-2081-2014: When liquid comes in contact with the DX-D 100 touch screen, the device may incorrectly recognize this as user input altering device settings.
- May 13, 2014 · Class III · Z-2176-2014: Unit was mislabeled with a factory label showing 32 KW output power.
- May 15, 2013 · Class II · Z-1487-2013: Customers could potentially experience intermittent, unintended and illogical movement when using the product.

## Indications for use
Agfa's DX-D 100 is indicated for use in providing diagnostic quality images to aid the physician with diagnosis. Systems can be used with MUSICA2 image processing to create radiographic images of the skeleton (including skull, spinal column and extremities) chest, abdomen and other body parts. Agfa's DX-D 100 is not indicated for use in mammography.

Source page: https://510kreport.com/device/K103597
Methodology: https://510kreport.com/methodology