510(k) Report

510(k) · Cleared

Cleared

1.5` Focal Spot Resolution Pattern

K810254510(k) TraditionalCleared Feb 19, 198120-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

Machlett Laboratories, Inc. · IXF Test-Pattern, Radiographic

Cleared on Feb 19, 1981 after a 20-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Feb 19, 1981
Review
20 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 K810254Source: 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.

  • 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 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 Machlett Laboratories, Inc.

4 FDA decisions under this applicant name. See the company

  • K813158RDP-2000Machlett Laboratories, Inc. · 1982
  • K802888Raytheon Medical ImagingMachlett Laboratories, Inc. · 1981
  • K780969Gamma CameraMachlett Laboratories, Inc. · 1978

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
  • K834482Tissue Mimicking Ultrasound PhantomsRadiation Measurements, Inc. · 1984
  • K834481Doppler Phantom Flow Control SysRadiation Measurements, Inc. · 1984

https://510kreport.com/device/K810254 · printed Nov 6, 2026

Cite this page

510(k) Report. “K810254: 1.5` Focal Spot Resolution Pattern.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K810254

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