# K993681: Digitec Two Stage Compression Kit

- Pathway: 510(k) (Traditional)
- Applicant: Digitec Medical Service Corp.
- Decided: Dec 21, 1999 after 50 days
- Product code: IZH (System, X-Ray, Mammographic)
- Device class: 2
- Regulation: 21 CFR 892.1710
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K881882 (1988). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K881882: Senographe 600T and 600TS Senix HF, General Electric Co. (1988) Summary page 1.

## Indications for use
The Digitec Two Stage Compression Kit is a modification for the GE Senographe 600T series x-ray mammography systems. It modifies two aspects of the compression system. First, the kit is intended to improve the “fine adjustment” control of the compression sequence. The original design of the compression system uses the same control method for applying initial compression force and for “fine adjustment” force. The kit does not change the method to apply initial compression force. It modifies the control sequence to achieve smoother fine adjustment control. “Fine adjustment” control is required to slowly and incrementally add the last little bit of compression just prior to making the exposure. The modification kit also repositions the compression paddle to be flat and parallel with the breast support plate. The original design elevates the chestwall edge of the compression paddle off of the breast support plate. The kit removes the 1.2-degree tilt of the original design. The kit is not intended to change the basic operation of the compression system, the operator controls, or the amount of compression force applied to the breast. Finally, the kit does not change the safety or compression release features in any way.

Source page: https://510kreport.com/device/K993681
Methodology: https://510kreport.com/methodology