510(k) · Cleared
Recalled · 2004Senographe 600T and 600TS Senix HF
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
General Electric Co. · IZH System, X-Ray, Mammographic
Cleared on May 25, 1988 after a 21-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 1 later device descends from it. It has been recalled once.
- Decided
- May 25, 1988
- Review
- 21 days
- Class
- Class II
- Product code
- IZH
- Recalls
- 1
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK881882 Senographe 600T and 600TS Senix HFGeneral Electric Co. · 1988
- Descendant · cites it directly · 0 of its ownK993681 Digitec Two Stage Compression KitDigitec Medical Service Corp. · 1999
Most influential descendants
Showing 1 of 1 · See all- K993681Digitec Two Stage Compression KitDigitec Medical Service Corp. · 1999 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K881882 | Senographe 600T and 600TS Senix HF | General Electric Co. | 1988 | — |
| +1 | K993681 | Digitec Two Stage Compression Kit | Digitec Medical Service Corp. | 1999 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K993681 | Digitec Two Stage Compression Kit | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 6, 2004 | Not classified | Z-0287-04 | Other | The mammography system's information for users lacked the technical specification for the minimum filtration permanently installed in the useful beam and the technical specification for the maximum line current. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K993681 (Digitec Medical Service Corp., 1999) has gone furthest, with 0 descendants of its own.
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 | — |
https://510kreport.com/device/K881882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K881882: Senographe 600T and 600TS Senix HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K881882
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026