510(k) Report

510(k) · Cleared

Cleared

Contour Mammography System, Model Number M-CTR

K925725510(k) TraditionalCleared Feb 26, 1993105-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

Bennett X-Ray Corp. · IZH System, X-Ray, Mammographic

Cleared on Feb 26, 1993 after a 105-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 3 later devices descend from it.

Decided
Feb 26, 1993
Review
105 days
Class
Class II
Product code
IZH
Recalls
None
Predicates
0

3 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 1999: 2 descendants cleared1997: 1 descendant cleared1990200020102020
  1. This deviceK925725 Contour Mammography System, Model Number M-CTRBennett X-Ray Corp. · 1993
  2. Descendant · cites it directly · 1 of its ownK964576 Profile Mammography System (M-Pro)Bennett X-Ray Corp. · 1997
  3. Descendant · cites it directly · 0 of its ownK984091 Contour 2000 Mammography System, Model CTR- 2000Trex Medical Corp. · 1999
  4. Descendant · 2 generations on · 0 of its ownK984092 Profile 2000 Mammography System, Pro-2000Trex Medical Corp. · 1999

Most influential descendants

Showing 3 of 3 · See all
  • K964576Profile Mammography System (M-Pro)Bennett X-Ray Corp. · 1997 · cites it directly1descendant
  • K984091Contour 2000 Mammography System, Model CTR- 2000Trex Medical Corp. · 1999 · cites it directly0descendants
  • K984092Profile 2000 Mammography System, Pro-2000Trex Medical Corp. · 1999 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K925725Contour Mammography System, Model Number M-CTRBennett X-Ray Corp.1993—
+1K964576Profile Mammography System (M-Pro)Bennett X-Ray Corp.1997—
+1K984091Contour 2000 Mammography System, Model CTR- 2000Trex Medical Corp.1999—
+2K984092Profile 2000 Mammography System, Pro-2000Trex Medical Corp.1999—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199920
FIG. 1 — Lineage of K925725, 1993–1999Source: 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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (3)

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K964576Profile Mammography System (M-Pro)Bennett X-Ray Corp.19971
K984091Contour 2000 Mammography System, Model CTR- 2000Trex Medical Corp.19990

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, K964576 (Bennett X-Ray Corp., 1997) has gone furthest, with 1 descendant 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—

More from Bennett X-Ray Corp.

23 FDA decisions under this applicant name. See the company

  • K964576Profile Mammography System (M-Pro)Bennett X-Ray Corp. · 1997
  • K952672Vertical Integrated Perfect View (Vip) Radiographic SystemBennett X-Ray Corp. · 1995
  • K944978Bennett X-Ray Digital Spot Imaging System Model M-DsiBennett X-Ray Corp. · 1995
  • K945962Bennett X-Ray Profile Positioning Paddle for MammographyBennett X-Ray Corp. · 1995
  • K945749Bennett X-Ray Tomography SystemBennett X-Ray Corp. · 1995

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/K925725 · printed Nov 6, 2026

Cite this page

510(k) Report. “K925725: Contour Mammography System, Model Number M-CTR.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K925725

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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