510(k) Report

510(k) · Cleared

Cleared

Planmed Sophie Nuance Classic

K042671510(k) TraditionalCleared Nov 19, 200451-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

Planmed OY · IZH System, X-Ray, Mammographic

Cleared on Nov 19, 2004 as substantially equivalent to K904953 (Planmeca USA, Inc., 1991) and 7 other predicates after a 51-day review. Its family tree reaches back 1 generation to 1991.

Decided
Nov 19, 2004
Review
51 days
Class
Class II
Product code
IZH
Recalls
None
Predicates
8

Its longest line of descent runs back 1 generation to K904953 (1991). 8 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2002: 1 other ancestor1999: 1 other ancestor1998: 1 other ancestor1997: 2 other ancestors1995: 1 other ancestor1992: 1 other ancestorK904953 · Planmed Sophie · Planmeca USA, Inc. · 19911990199520002005
Other ancestors, by generation 1 generation back: 7 other ancestors K904953 · Planmed Sophie · Planmeca USA, Inc. · 19910
  1. Root · 1 generation backK904953 Planmed SophiePlanmeca USA, Inc. · 1991
  2. This deviceK042671 Planmed Sophie Nuance ClassicPlanmed OY · 2004
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K904953Planmed SophiePlanmeca USA, Inc.1991—
0 (this device)K042671Planmed Sophie Nuance ClassicPlanmed OY2004—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199210
199510
199720
199810
199910
200210
FIG. 1 — Lineage of K042671, 1991–2004Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (8)

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
*K904953Planmed Sophie
Summary page 1
…We consider this product to be similar in design, composition and function to the following devices introduced into commercial distribution after May 28, 1976: # K904953 Planmed Sophie ENCLOSURE 12…
Planmeca USA, Inc.1991—
*K923471Planmed Cytoguide
Summary page 2
…ENCLOSURE 12 P. 12-2 # K923471 Planmed Sophie with Cytoguide # K951883 Planmed Sophie modification # K962105 Planmed Sophie Classic…
Planmed OY1992—
*K951883Planmed Sophie Mammographic X-Ray Unit
Summary page 2
…ENCLOSURE 12 P. 12-2 # K923471 Planmed Sophie with Cytoguide # K951883 Planmed Sophie modification # K962105 Planmed Sophie Classic # K973493 Planmed Sophie Classic with Cyt…
Planmed OY1995—
*K962105Planned Sophied Classic
Summary page 2
…P. 12-2 # K923471 Planmed Sophie with Cytoguide # K951883 Planmed Sophie modification # K962105 Planmed Sophie Classic # K973493 Planmed Sophie Classic with Cytoguide # K983659 Planreed Sophie modif…
Planmed OY1997—
*K973493Planmed Cytoguide
Summary page 2
…P. 12-2 # K923471 Planmed Sophie with Cytoguide # K951883 Planmed Sophie modification # K962105 Planmed Sophie Classic # K973493 Planmed Sophie Classic with Cytoguide # K983659 Planreed Sophie modification # K991826 Planmed Sophie…
Planmed OY1997—
*K983659Planmed Sophie & Planned Sophie Classic
Summary page 2
…Cytoguide # K951883 Planmed Sophie modification # K962105 Planmed Sophie Classic # K973493 Planmed Sophie Classic with Cytoguide # K983659 Planreed Sophie modification # K991826 Planmed Sophie with Maxview # K013656 Planmed Sophie modificati…
Planmed OY1998—
*K991826Planmed Sophie and Sophie Classic
Summary page 2
…fication # K962105 Planmed Sophie Classic # K973493 Planmed Sophie Classic with Cytoguide # K983659 Planreed Sophie modification # K991826 Planmed Sophie with Maxview # K013656 Planmed Sophie modification # K021945 Planmed Sophie with Digigu…
Planmed OY1999—
*K013656Planmed Sophie & Planmed Sophie Classic
Summary page 2
…sic # K973493 Planmed Sophie Classic with Cytoguide # K983659 Planreed Sophie modification # K991826 Planmed Sophie with Maxview # K013656 Planmed Sophie modification # K021945 Planmed Sophie with Digiguide…
Planmed OY2002—

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?

  • None of the 8 ancestors has a recall.

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?

The Planmed Sophie Nuance Classic is a mammography x-ray system, which is intended to be used to produce radiographs of the human breast. The device can be equipped with accessories to fulfil different diagnostic needs. Spot mammography is only used in combination with stereotactic needle biopsy guidance.

Indications for use as stated in the FDA summary.

More from Planmed OY

20 FDA decisions under this applicant name. See the company

  • K250318Planmed XFIPlanmed OY · 2025
  • K211720Planmed Clarity 2D, Planmed Clarify SPlanmed OY · 2022
  • K213278Planmed VerityPlanmed OY · 2022
  • K192317Planmed Clarity 2D and Clarity SPlanmed OY · 2020
  • K180918Planmed VerityPlanmed OY · 2018

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/K042671 · printed Nov 4, 2026

Cite this page

510(k) Report. “K042671: Planmed Sophie Nuance Classic.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K042671

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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