510(k) · Cleared
ClearedGiotto Image
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medx, Inc. · IZH System, X-Ray, Mammographic
Cleared on Nov 30, 2001 as substantially equivalent to K973856 (Sitco, Inc., 1997) after an 87-day review. Its family tree reaches back 2 generations to 1990. 1 later device descends from it.
- Decided
- Nov 30, 2001
- Review
- 87 days
- Class
- Class II
- Product code
- IZH
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K901558 (1990). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK901558 Giotto Mammography HFMedical Device Marketing Network, Inc. · 1990
- 1 generation backK973856 Giotto HTSitco, Inc. · 1997
- This deviceK012953 Giotto ImageMedx, Inc. · 2001
- Descendant · cites it directly · 0 of its ownK111434 Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC · 2011
Most influential descendants
Showing 1 of 1 · See all- K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K901558 | Giotto Mammography HF | Medical Device Marketing Network, Inc. | 1990 | — |
| −1 | K973856 | Giotto HT | Sitco, Inc. | 1997 | — |
| 0 (this device) | K012953 | Giotto Image | Medx, Inc. | 2001 | — |
| +1 | K111434 | Giotto Image 3D, Giotto Image 3D-L | Giotto USA, LLC | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 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 |
|---|---|---|---|
| * | K973856 | Giotto HTSummary page 1…Device Name 2.1. Classification Name: System Mammographic Classification Number: 90IZH 2.2, Trade/Proprietary Name: Giotto Image 2.3. Predicate Device: Giotto HT (DC K973856) 3. Device Description 3.1. Function Kos2553 duel42 The Giotto Image is a conventional film-screen x-ray mammographic device… | 1997 |
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 |
|---|---|---|---|
| K111434 | Giotto Image 3D, Giotto Image 3D-L | 2011 | 0 |
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 11 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K111434 (Giotto USA, LLC, 2011) 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 | — |
What is it indicated for?
The Giotto Image X-ray Mammographic System is intended to provide film-screen X-ray imaging of the breast that can be imaged on a 18 x 24cm or 24 x 30cm film. With optional accessories the Giotto Image can also be used as the imaging device for stereotactic needle biopsy.
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/K012953 · printed Nov 4, 2026
Cite this page
510(k) Report. “K012953: Giotto Image.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K012953
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026