510(k) Report

510(k) · Cleared

Cleared

Giotto Mammography HF

K901558510(k) TraditionalCleared Jul 3, 199091-day reviewClass II21 CFR 892.1710

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Medical Device Marketing Network, Inc. · IZH System, X-Ray, Mammographic

Cleared on Jul 3, 1990 after a 91-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.

Decided
Jul 3, 1990
Review
91 days
Class
Class II
Product code
IZH
Recalls
None
Predicates
0

3 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2001: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK901558 Giotto Mammography HFMedical Device Marketing Network, Inc. · 1990
  2. Descendant · cites it directly · 2 of its ownK973856 Giotto HTSitco, Inc. · 1997
  3. Descendant · 2 generations on · 1 of its ownK012953 Giotto ImageMedx, Inc. · 2001
  4. Descendant · 3 generations on · 0 of its ownK111434 Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC · 2011

Most influential descendants

Showing 3 of 3 · See all
  • K973856Giotto HTSitco, Inc. · 1997 · cites it directly2descendants
  • K012953Giotto ImageMedx, Inc. · 2001 · 2 generations on1descendant
  • K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC · 2011 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K901558Giotto Mammography HFMedical Device Marketing Network, Inc.1990—
+1K973856Giotto HTSitco, Inc.1997—
+2K012953Giotto ImageMedx, Inc.2001—
+3K111434Giotto Image 3D, Giotto Image 3D-LGiotto USA, LLC2011—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
200110
201110
FIG. 1 — Lineage of K901558, 1990–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
Get a 510(k) Report

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? (3)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973856Giotto HTSitco, Inc.19972

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?

  • Of its descendants, K973856 (Sitco, Inc., 1997) has gone furthest, with 2 descendants of its own.

How does its category compare?

All IZH devices

IZH System, X-Ray, Mammographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZH

1in 2021

2007: 32008: 12010: 22011: 12012: 22013: 22015: 12016: 32019: 12020: 12021: 1
2007high 3 (2007) · low 0 (2009)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZH

64in 2016

2007: 30 days median2016: 64 days median
2007high 64 (2016) · low 30 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IZH

2in 2008

2008: 2
2007high 2 (2008) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZH

15in 2025

2007: 112008: 52009: 142010: 72011: 52012: 182013: 92014: 72015: 82016: 92017: 122018: 252019: 392020: 72021: 92022: 42023: 82024: 52025: 15
2007high 39 (2019) · low 4 (2022)2025

MAUDE reports naming product code IZH, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007330011
20081—25
20090—014
20102—07
20111—05
20122—018
20132—09
20140—07
20151—08
201636409
20170—012
20180—025
20191—039
20201—07
20211—09
20220—04
20230—08
20240—05
20250—015
20260—0—

Recent decisions in IZH

The IZH category page

  • K203509Smart FinderIms Giotto S.P.A. · 2021
  • K202294Affirm Contrast BiopsyHologic, Inc. · 2020
  • K191495Biopsy PositionerFujifilm Corporation · 2019
  • K161575Affirm Lateral Arm Upright Biopsy AccessoryHologic · 20161 recall
  • K161920Comfort CoverPrecision Dynamics Corporation · 2016

https://510kreport.com/device/K901558 · printed Nov 6, 2026

Cite this page

510(k) Report. “K901558: Giotto Mammography HF.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K901558

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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