510(k) Report

510(k) · Cleared

Cleared

Polyscan Digital Scanner

K944684510(k) TraditionalCleared May 15, 1995235-day reviewClass I21 CFR 892.1300

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

Mse Medizintechnik GmbH & Co. KG · IYW Scanner, Rectilinear, Nuclear

Cleared on May 15, 1995 after a 235-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
May 15, 1995
Review
235 days
Class
Class I
Product code
IYW
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 K944684Source: 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 IYW devices

IYW Scanner, Rectilinear, Nuclear: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYW

FDA has decided no IYW device since 2007.

Median 510(k) review, days · IYW

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

Recalls per year · IYW

No recall names IYW since 2007.

Adverse event reports per year · IYW

No MAUDE report names IYW 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—

Recent decisions in IYW

The IYW category page

  • K895799Rectilinear Scanner Model #187-270Atomic Products Corp. · 1990
  • K882453Polyscan Digital ScannerMedical and Scientific Enterprises, Inc. · 1988
  • K780395Imager, Body Section, RadionuclideUnion Carbide Corp. · 1978

https://510kreport.com/device/K944684 · printed Nov 5, 2026

Cite this page

510(k) Report. “K944684: Polyscan Digital Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K944684

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