510(k) · Cleared
ClearedBiopsy M
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sitco, Inc. · IZH System, X-Ray, Mammographic
Cleared on Jul 14, 1998 as substantially equivalent to K933430 (Gold Coast Imaging, Inc., 1994) after a 33-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Jul 14, 1998
- Review
- 33 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K933430 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK933430 Cytoguide Stereotatic Biopsy SystemGold Coast Imaging, Inc. · 1994
- This deviceK982049 Biopsy MSitco, Inc. · 1998
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K933430 | Cytoguide Stereotatic Biopsy System | Gold Coast Imaging, Inc. | 1994 | — |
| 0 (this device) | K982049 | Biopsy M | Sitco, Inc. | 1998 | — |
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 |
|---|---|---|---|
| * | K933430 | Cytoguide Stereotatic Biopsy SystemSummary page 1…2. Device Name 2.1. 2.2 2.3. Classification Name: System Mammographic Classification Number: 901ZH Trade/Proprietary Name: Biopsy M Predicate Device: Cytoguide (DC K933430) 3. Device Description 3.1 Function The Biopsy-M device uses two stereo images on a‘filin to determine the location of a lesi… | 1994 |
| † | K973856 | Giotto HT | 1997 |
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 no 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 intended uses of the Biopsy M are mammographic procedures requiring stereotactic guidance, such as fine needle aspiration, needle biopsy and guide wire placement.
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/K982049 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982049: Biopsy M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982049
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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