510(k) Report

510(k) · Cleared

Cleared

Mammoloader by C.M.a. SRL

K973125510(k) TraditionalCleared Oct 8, 199749-day reviewClass II21 CFR 892.1900

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

C.M.A. · IXW Processor, Radiographic-Film, Automatic

Cleared on Oct 8, 1997 as substantially equivalent to K905607 (Eastman Kodak Company, 1991) after a 49-day review. Its family tree reaches back 1 generation to 1991.

Decided
Oct 8, 1997
Review
49 days
Class
Class II
Product code
IXW
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K905607 (1991). No later device cites it as a predicate yet.

K905607 · Kodak X-Omat Multiloader 300 · Eastman Kodak Company · 199119901992199419961998
K905607 · Kodak X-Omat Multiloader 300 · Eastman Kodak Company · 19910
  1. Root · 1 generation backK905607 Kodak X-Omat Multiloader 300Eastman Kodak Company · 1991
  2. This deviceK973125 Mammoloader by C.M.a. SRLC.M.A. · 1997
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K905607Kodak X-Omat Multiloader 300Eastman Kodak Company1991—
0 (this device)K973125Mammoloader by C.M.a. SRLC.M.A.1997—
FIG. 1 — Lineage of K973125, 1991–1997Source: 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 IXW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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.

TypeNumberDeviceApplicantDecidedRecalls
*K905607Kodak X-Omat Multiloader 300
Summary page 1
…fication for the above referenced product contains adequate information and data to enable CDRH to determine substantial equivalence to the KODAK X-OMAT Multiloader 300 (K905607). This information and data is summarized as follows: 1. The MAMMOLOADER system is subject to and in compliance with the Federal…
Eastman Kodak Company1991—

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?

  • Its one ancestor has no recall.

How does its category compare?

All IXW devices

IXW Processor, Radiographic-Film, Automatic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXW

1in 2011

2009: 12010: 12011: 1
2007high 1 (2009) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IXW

Too few IXW 510(k)s in any year since 2007 to give a median.

Recalls per year · IXW

No recall names IXW since 2007.

Adverse event reports per year · IXW

2in 2018

2008: 12009: 22014: 22015: 22016: 12017: 12018: 2
2007high 2 (2009) · low 0 (2007)2025

MAUDE reports naming product code IXW, 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
20070—00
20080—01
20091—02
20101—00
20111—00
20120—00
20130—00
20140—02
20150—02
20160—01
20170—01
20180—02
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

What is it indicated for?

The MAMMOLQOADER is a device designed to unload and or load medical imaging films from the KODAK Mammography film cassettes (18x24 cm & 24x30 cm) and KODAK Video Film Holder (8x10 in), under roomlight conditions.

Two versions are available; integrated with a medical imaging film processor so that when film cassettes are unloaded the film is sent directly into the film processor, or in a stand-alone version in which exposed films are unloaded from cassettes and placed into a receive magazine for processing at a later time.

Typical users of this system are trained medical professionals, including but not limited to physicians, nurses and lab technicians.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Recent decisions in IXW

The IXW category page

  • K111167Xtender Film Processor, Sprint Film Processor Model Xtender Model SprintVelopex International, Inc. · 2011
  • K093503Intrax Film ProcessorVelopex International, Inc. · 2010
  • K091628Optimax, Compact 2, Optimax 2010, EcomaxProtec GmbH & Co. KG · 2009
  • K024342Radiographic Film Processor, Models XP400 and XP1000Daito Co., Ltd. · 2003
  • K023825Film Processor, Model Life Ray Pro 2500S.a.I.E.P. S.R.L. · 2003

https://510kreport.com/device/K973125 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973125: Mammoloader by C.M.a. SRL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973125

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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