510(k) · Cleared

Cleared

Equal Dose 1.0

K073273510(k) TraditionalCleared Dec 11, 200720-day reviewClass II21 CFR 892.5050

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

Nucletron Corporation · IYE Accelerator, Linear, Medical

Cleared on Dec 11, 2007 as substantially equivalent to K011246 (Mds Nordion, 2001) after a 20-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Dec 11, 2007
Review: 20 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K011246 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK011246 DCM 1.0Mds Nordion · 2001
This deviceK073273 Equal Dose 1.0Nucletron Corporation · 2007
Descendant · cites it directly · 0 of its ownK103515 Equal DoseNucletron Corporation · 2011

Most influential descendants

Showing 1 of 1 · See all

K103515Equal DoseNucletron Corporation · 2011 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K011246	DCM 1.0	Mds Nordion	2001	—
0 (this device)	K073273	Equal Dose 1.0	Nucletron Corporation	2007	—
+1	K103515	Equal Dose	Nucletron Corporation	2011	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0

FIG. 1 — Lineage of K073273, 2001–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in IYE? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new IYE device

#1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
#2 Held for the reportin the report
#3 Held for the reportin the report

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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

Type	Number	Device	Applicant	Decided	Recalls
*	K011246	DCM 1.0 Summary page 1 …ble below: Manufacturer Device 510(k #. MDS Nordion DCM1.0 K011246 Description: MUV 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performe…	Mds Nordion	2001	—

Also cleared against K011246: 2 other devices →

What descends from it? (1)

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

Number	Device	Applicant	Decided	Descendants
K103515	Equal Dose	Nucletron Corporation	2011	0

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?

Its one ancestor has no recall.
Of its descendants, K103515 (Nucletron Corporation, 2011) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K011246.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.

FDA decisions per year · IYE

12in 2025

2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007high 239 (2024) · low 44 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · IYE

1in 2025

2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, not matched to any one device; reports are not rates.

View these four charts as a table

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	23	44	78	155
2008	14	69	49	114
2009	20	63	22	174
2010	23	74	27	246
2011	11	94	73	280
2012	28	106	20	128
2013	18	88	11	96
2014	20	100	14	124
2015	20	108	8	100
2016	21	97	7	97
2017	23	94	7	125
2018	21	58	7	85
2019	19	83	2	91
2020	20	67	4	74
2021	19	86	5	68
2022	12	172	3	66
2023	18	129	7	128
2024	9	239	1	81
2025	12	170	1	101
2026	14	120	4	—

What is it indicated for?

EQUAL Dose 1.0 is a quality assurance (QA) tool intended for independent verification of the dose calculations performed during treatment planning for external beam therapy, prior to the clinical treatment start.

The intended user is a medical physicist or someone well familiar with the dosimetric concepts that are of importance in external beam therapy.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K073273 · printed Nov 6, 2026

Cite this page

510(k) Report. “K073273: Equal Dose 1.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073273

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Record history

FDA decision record loaded May 2, 2026
Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026