510(k) · Cleared
ClearedBiopsy Digit-AM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Giotto USA, LLC · IZH System, X-Ray, Mammographic
Cleared on Sep 11, 2006 as substantially equivalent to K990192 (Sitco, Inc., 1999) after a 54-day review. Its family tree reaches back 2 generations to 1992. 2 later devices descend from it.
- Decided
- Sep 11, 2006
- Review
- 54 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K923061 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK923061 MammoscanFischer Imaging Corp. · 1992
- 1 generation backK990192 Biopsy-DigitSitco, Inc. · 1999
- This deviceK062039 Biopsy Digit-AMGiotto USA, LLC · 2006
- Descendant · cites it directly · 1 of its ownK113607 Biopsy Digit S Biopsy SLGiotto USA, LLC · 2012
- Descendant · 2 generations on · 0 of its ownK163388 XPress BCD Breast Compression DeviceXpress Bcd, LLC · 2017
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K923061 | Mammoscan | Fischer Imaging Corp. | 1992 | — |
| −1 | K990192 | Biopsy-Digit | Sitco, Inc. | 1999 | — |
| 0 (this device) | K062039 | Biopsy Digit-AM | Giotto USA, LLC | 2006 | — |
| +1 | K113607 | Biopsy Digit S Biopsy SL | Giotto USA, LLC | 2012 | — |
| +2 | K163388 | XPress BCD Breast Compression Device | Xpress Bcd, LLC | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
| 2017 | 1 | 0 |
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 |
|---|---|---|---|
| * | K990192 | Biopsy-DigitSummary page 1…fication Number: 9017H 2.2. Trade/Proprietary Name: BIOPSY DIGIT-AM 2.3. Predicate Device: BIOPSY DIGIT (DC K990192) 3. Device Description 3.1. Function The BIOPSY DIGIT-AM device uses two stereo images taken by a… | 1999 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K113607 | Biopsy Digit S Biopsy SL | 2012 | 1 |
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?
- The line of descent spans 14 years and passes through 3 companies; a new generation was cleared every 7.5 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K113607 (Giotto USA, LLC, 2012) has gone furthest, with 1 descendant 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 | — |
What is it indicated for?
The Biopsy Digit-AM is intended to be used for mammographic procedures requiring
stereotactic guidance, such as fine needle aspiration, needle biopsy, and guide wire
placement.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062039 · printed Nov 6, 2026
Cite this page
510(k) Report. “K062039: Biopsy Digit-AM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K062039
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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