510(k) Report

510(k) · Cleared

Cleared

Tissue Mimicking Ultrasound Phantoms

K834482510(k) TraditionalCleared Jan 25, 198441-day reviewClass I21 CFR 892.1940

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

Radiation Measurements, Inc. · IXF Test-Pattern, Radiographic

Cleared on Jan 25, 1984 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 25, 1984
Review
41 days
Class
Class I
Product code
IXF
Recalls
None
Predicates
0

FDA has not posted a summary or statement for it, so its predicates are not known.

FIG. 1 — Lineage of K834482Source: 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 IXF? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

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  • Recall history across each candidate’s familyin the report
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What was it cleared against?

FDA has not posted a summary or statement for it, 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 IXF devices

IXF Test-Pattern, Radiographic: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IXF

FDA has decided no IXF device since 2007.

Median 510(k) review, days · IXF

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

Recalls per year · IXF

No recall names IXF since 2007.

Adverse event reports per year · IXF

No MAUDE report names IXF 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 Radiation Measurements, Inc.

12 FDA decisions under this applicant name. See the company

  • K893216Rmi Ultrasound Doppler Phantom SystemRadiation Measurements, Inc. · 1989
  • K885223Rmi Short Distance Alignment DeviceRadiation Measurements, Inc. · 1989
  • K873956UltimeterRadiation Measurements, Inc. · 1987
  • K873836Mammographic KVP Meter Model 232Radiation Measurements, Inc. · 1987
  • K854976Rmi Respiratory Gating System Model 301Radiation Measurements, Inc. · 1986

Recent decisions in IXF

The IXF category page

  • K865100Tissue-Equivalent Breast SimulatorComputerized Imaging Reference Systems, Inc. · 1987
  • K851812Digital Subtraction Antiography Phantom 76-700/711Victoreen, Inc. · 1985
  • K834481Doppler Phantom Flow Control SysRadiation Measurements, Inc. · 1984
  • K8102541.5` Focal Spot Resolution PatternMachlett Laboratories, Inc. · 1981

https://510kreport.com/device/K834482 · printed Nov 5, 2026

Cite this page

510(k) Report. “K834482: Tissue Mimicking Ultrasound Phantoms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K834482

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