510(k) · Cleared
ClearedDigitec Two Stage Compression Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Digitec Medical Service Corp. · IZH System, X-Ray, Mammographic
Cleared on Dec 21, 1999 as substantially equivalent to K881882 (General Electric Co., 1988) after a 50-day review. Its family tree reaches back 1 generation to 1988.
- Decided
- Dec 21, 1999
- Review
- 50 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K881882 (1988). No later device cites it as a predicate yet.
- Root · 1 generation backK881882 Senographe 600T and 600TS Senix HFGeneral Electric Co. · 1988 · Recalled
- This deviceK993681 Digitec Two Stage Compression KitDigitec Medical Service Corp. · 1999
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K881882 | Senographe 600T and 600TS Senix HF | General Electric Co. | 1988 | 1 |
| 0 (this device) | K993681 | Digitec Two Stage Compression Kit | Digitec Medical Service Corp. | 1999 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in IZH? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new IZH device
- #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K881882 | Senographe 600T and 600TS Senix HFSummary page 1…ubstantial equivalence is being claimed is the GE Senographe 600T and 600Ts. X-ray mammography systems. The 510(k)- document control number for this comparison device is K881882. Description of Device The Digitec Two Stage Compression Kit is an accessory item designed for use in the GE Senographe 600T se… | 1988 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
How does its category compare?
All IZH devicesIZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IZH
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · IZH
64in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IZH
2in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IZH
15in 2025
MAUDE reports naming product code IZH, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 30 | 0 | 11 |
| 2008 | 1 | — | 2 | 5 |
| 2009 | 0 | — | 0 | 14 |
| 2010 | 2 | — | 0 | 7 |
| 2011 | 1 | — | 0 | 5 |
| 2012 | 2 | — | 0 | 18 |
| 2013 | 2 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 7 |
| 2015 | 1 | — | 0 | 8 |
| 2016 | 3 | 64 | 0 | 9 |
| 2017 | 0 | — | 0 | 12 |
| 2018 | 0 | — | 0 | 25 |
| 2019 | 1 | — | 0 | 39 |
| 2020 | 1 | — | 0 | 7 |
| 2021 | 1 | — | 0 | 9 |
| 2022 | 0 | — | 0 | 4 |
| 2023 | 0 | — | 0 | 8 |
| 2024 | 0 | — | 0 | 5 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
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…
Read the full statement (195 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K993681 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993681: Digitec Two Stage Compression Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993681
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026