510(k) Report

510(k) · Cleared

Cleared

Performa Stereo

K023864510(k) TraditionalCleared Jan 9, 200350-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

Instrumentarium Corp. Imaging Division · IZH System, X-Ray, Mammographic

Cleared on Jan 9, 2003 as substantially equivalent to K934478 (Instrumentarium Corp., 1995) and 2 other predicates after a 50-day review. Its family tree reaches back 1 generation to 1989.

Decided
Jan 9, 2003
Review
50 days
Class
Class II
Product code
IZH
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K884107 (1989). 3 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 1995: 2 other ancestorsK884107 · Stereotactic Biopsy Attachment · Siemens Medical Solutions USA, Inc. · 198919851990199520002005
Other ancestors, by generation 1 generation back: 2 other ancestors K884107 · Stereotactic Biopsy Attachment · Siemens Medical Solutions USA, Inc. · 19890
  1. Root · 1 generation backK884107 Stereotactic Biopsy AttachmentSiemens Medical Solutions USA, Inc. · 1989
  2. This deviceK023864 Performa StereoInstrumentarium Corp. Imaging Division · 2003
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K884107Stereotactic Biopsy AttachmentSiemens Medical Solutions USA, Inc.1989—
0 (this device)K023864Performa StereoInstrumentarium Corp. Imaging Division2003—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199520
FIG. 1 — Lineage of K023864, 1989–2003Source: 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), 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. #1 K202294 Affirm Contrast Biopsyscore 1.0 · 4 generations · no Class I recall
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K934478Alpha Stereo
Summary page 1
…following devices introduced into commercial distribution after May 28, 1976: Alpha Stereo 4 #K934478 GE Stereotix 2 #K941191 Siemens Mammomat 3000 Stereo…
Instrumentarium Corp.1995—
*K941191Real Time Stereotix
Summary page 1
…1976: Alpha Stereo 4 #K934478 GE Stereotix 2 #K941191 Siemens Mammomat 3000 Stereo #K884 107 The comparison of characterist…
GE Medical Systems19952
*K884107Stereotactic Biopsy Attachment
Summary page 1
…#K934478 GE Stereotix 2 #K941191 Siemens Mammomat 3000 Stereo #K884 107 The comparison of characteristics supports substantial equivalence. The Performa Ste…
Siemens Medical Solutions USA, Inc.1989—

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?

  • 1 of the 3 ancestors has a recall of any class.

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—

What is it indicated for?

Performa Stereo is intended to be used for breast biopsy or lesion marking with the base mammographic system Performa with stereo adapter.

Indications for use as stated in the FDA summary.

More from Instrumentarium Corp. Imaging Division

3 FDA decisions under this applicant name. See the company

  • K043612Orthopantomograph OP200, OP200D, and Orthoceph OC200, OC200DInstrumentarium Corp. Imaging Division · 2005
  • K022275Delta 32; Delta 32 TactInstrumentarium Corp. Imaging Division · 2002

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/K023864 · printed Nov 6, 2026

Cite this page

510(k) Report. “K023864: Performa Stereo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K023864

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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