510(k) Report

510(k) · Cleared

Cleared

Jeol Model #JTG-500M

K823041510(k) TraditionalCleared Nov 24, 198241-day reviewClass III21 CFR 884.2980

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

Jeol · IYM System, Telethermographic, Infrared

Cleared on Nov 24, 1982 after a 41-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.

Decided
Nov 24, 1982
Review
41 days
Class
Class III
Product code
IYM
Recalls
None
Predicates
0

4 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 1999: 1 descendant cleared2004: 1 descendant cleared2017: 1 descendant cleared2016: 1 descendant cleared19801990200020102020
  1. This deviceK823041 Jeol Model #JTG-500MJeol · 1982
  2. Descendant · cites it directly · 3 of its ownK990416 Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999
  3. Descendant · 2 generations on · 2 of its ownK032350 Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004
  4. Descendant · 3 generations on · 0 of its ownK162767 Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017
  5. Descendant · 3 generations on · 0 of its ownK160573 FirstSense Breast ExamFirst Sense Medical, LLC · 2016

Most influential descendants

Showing 4 of 4 · See all
  • K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc. · 1999 · cites it directly3descendants
  • K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp. · 2004 · 2 generations on2descendants
  • K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC · 2017 · 3 generations on0descendants
  • K160573FirstSense Breast ExamFirst Sense Medical, LLC · 2016 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K823041Jeol Model #JTG-500MJeol1982—
+1K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc.1999—
+2K032350Infrared Sciences Breastscan IR SystemInfrared Sciences Corp.2004—
+3K162767Sentinel BreastScan II SystemFirst Sense Medical, LLC2017—
+3K160573FirstSense Breast ExamFirst Sense Medical, LLC2016—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199910
200410
201610
201710
FIG. 1 — Lineage of K823041, 1982–2017Source: FDA 510(k) summaries, read by 510(k) Report · 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 has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (4)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K990416Omnicorder Bioscan SystemOmnicorder Technologies, Inc.19993

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.

What does this lineage say?

  • Of its descendants, K990416 (Omnicorder Technologies, Inc., 1999) has gone furthest, with 3 descendants of its own.

How does its category compare?

All IYM devices

IYM System, Telethermographic, Infrared: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYM

FDA has decided no IYM device since 2007.

Median 510(k) review, days · IYM

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

Recalls per year · IYM

No recall names IYM since 2007.

Adverse event reports per year · IYM

No MAUDE report names IYM 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 IYM

The IYM category page

  • K863736FMS Model 110Flir Medical Systems · 1986
  • K852950VisithermC.D. Regelin & Associates, Inc. · 1986
  • K812799DCATSDorex, Inc. · 1981
  • K812701Ortho-Therm Infrared SensorOrthion Corp. · 1981
  • K801553ThermocompHospital Financial Corp. · 1980

https://510kreport.com/device/K823041 · printed Nov 4, 2026

Cite this page

510(k) Report. “K823041: Jeol Model #JTG-500M.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K823041

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