510(k) Report

510(k) · Cleared

Cleared

MPQ-42

K934944510(k) TraditionalCleared Dec 15, 199358-day reviewClass II21 CFR 892.1870

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

Elema-Schonander, Inc. · IZP Programmer, Changer, Film/Cassette, Radiographic

Cleared on Dec 15, 1993 after a 58-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Dec 15, 1993
Review
58 days
Class
Class II
Product code
IZP
Recalls
None
Predicates
0

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

FIG. 1 — Lineage of K934944Source: FDA 510(k) database · 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.

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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?

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.

How does its category compare?

All IZP devices

IZP Programmer, Changer, Film/Cassette, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZP

FDA has decided no IZP device since 2007.

Median 510(k) review, days · IZP

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

Recalls per year · IZP

No recall names IZP since 2007.

Adverse event reports per year · IZP

No MAUDE report names IZP since 2007.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20080—00
20090—00
20100—00
20110—00
20120—00
20130—00
20140—00
20150—00
20160—00
20170—00
20180—00
20190—00
20200—00
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Elema-Schonander, Inc.

11 FDA decisions under this applicant name. See the company

  • K904103SEP 90Elema-Schonander, Inc. · 1990
  • K903576PUCK 90MElema-Schonander, Inc. · 1990
  • K842903Sep Programmer for Puck U & UD FilmchangElema-Schonander, Inc. · 1984
  • K842911Puck U & UD Cutfilm ChangersElema-Schonander, Inc. · 1984
  • K840389Sep Programmer Sep-M/Single-Plane &Elema-Schonander, Inc. · 1984

Recent decisions in IZP

The IZP category page

  • K911888Philips AngioproPhilips Medical Systems North America, Inc. · 1991
  • K904144Pulmovision Chest Radiography X-Ray SystemMallinckrodt Group, Inc. · 1990
  • K904103SEP 90Elema-Schonander, Inc. · 1990
  • K874451Omniplane 200 Film Changer SystemMedrad, Inc. · 1988
  • K854251The Cse Film Changer SystemChanger Service & Engineering, Inc. · 1985

https://510kreport.com/device/K934944 · printed Nov 4, 2026

Cite this page

510(k) Report. “K934944: MPQ-42.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K934944

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Record history
  • FDA decision record loaded May 2, 2026
  • Page last updated Nov 3, 2026