510(k) Report

510(k) · Cleared

Cleared

Tosbee

K914583510(k) TraditionalCleared Jan 28, 1993470-day reviewClass II21 CFR 892.5900

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

Toshiba America Medical Systems, In.C · IYD Generator, Low Voltage, Therapeutic X-Ray

Cleared on Jan 28, 1993 after a 470-day review. FDA has not posted a summary or statement for it, so its predicates are not known.

Decided
Jan 28, 1993
Review
470 days
Class
Class II
Product code
IYD
Recalls
None
Predicates
0

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

FIG. 1 — Lineage of K914583Source: 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 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 IYD devices

IYD Generator, Low Voltage, Therapeutic X-Ray: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYD

FDA has decided no IYD device since 2007.

Median 510(k) review, days · IYD

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

Recalls per year · IYD

No recall names IYD since 2007.

Adverse event reports per year · IYD

5in 2023

2023: 5
2007high 5 (2023) · low 0 (2007)2025

MAUDE reports naming product code IYD, 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—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—05
20240—00
20250—00
20260—0—

More from Toshiba America Medical Systems, In.C

146 FDA decisions under this applicant name. See the company

  • K141472Vantage ElanToshiba America Medical Systems, In.C · 2014
  • K133553KalareToshiba America Medical Systems, In.C · 20143 recalls
  • K140729Aplio Artida, V3.2Toshiba America Medical Systems, In.C · 2014
  • K132106Infinix Angio Workstation W/DTS SoftwareToshiba America Medical Systems, In.C · 2013
  • K131822Ultraextend Usws-900A V2.1 and V3.1Toshiba America Medical Systems, In.C · 2013

https://510kreport.com/device/K914583 · printed Nov 4, 2026

Cite this page

510(k) Report. “K914583: Tosbee.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K914583

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