510(k) Report

510(k) · Cleared

Cleared

Rinn Universal Collimator

K932134510(k) TraditionalCleared Jul 26, 199384-day reviewClass II21 CFR 892.1610

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

Rinn Corp. · IZX Collimator, Manual, Radiographic

Cleared on Jul 26, 1993 after an 84-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

Decided
Jul 26, 1993
Review
84 days
Class
Class II
Product code
IZX
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 K932134Source: 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.

Planning a device in IZX? 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?

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 IZX devices

IZX Collimator, Manual, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IZX

1in 2011

2010: 12011: 1
2007high 1 (2010) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IZX

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

Recalls per year · IZX

1in 2011

2007: 32011: 1
2007high 3 (2007) · low 0 (2008)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · IZX

1in 2014

2007: 12014: 1
2007high 1 (2007) · low 0 (2008)2025

MAUDE reports naming product code IZX, 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—31
20080—00
20090—00
20101—00
20111—10
20120—00
20130—00
20140—01
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 Rinn Corp.

5 FDA decisions under this applicant name. See the company

  • K913885Rinn E-Z CapperRinn Corp. · 1991
  • K828605Beam Limiting DeviceRinn Corp. · 1983
  • K813378Uni-Bite Dental X-Ray Film HolderRinn Corp. · 1982
  • K772313X-Ray CO-OrdinatorRinn Corp. · 1978

Recent decisions in IZX

The IZX category page

  • K110856RALCORalco S.R.L. · 2011
  • K101036Shimadzu Collimator R-20JShimadzu Corp. · 20101 recall
  • K042840Shimadzu Collimator R-20JShimadzu Corp. · 2004
  • K031771Shimadzu Collimator R-30HShimadzu Corp. · 2003
  • K981267Facts MonoblockDynarad Corp. · 1998

https://510kreport.com/device/K932134 · printed Nov 6, 2026

Cite this page

510(k) Report. “K932134: Rinn Universal Collimator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K932134

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