510(k) · Cleared

Cleared

Protos Software

K040709510(k) TraditionalCleared Apr 28, 200441-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

Aktina Medical Physics Corp. · IYE Accelerator, Linear, Medical

Cleared on Apr 28, 2004 as substantially equivalent to K935928 (Radiological Imaging Technology, Inc., 1994) after a 41-day review. Its family tree reaches back 1 generation to 1994.

Decided: Apr 28, 2004
Review: 41 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K935928 (1994). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK935928 Rit 113 Film Analysis SystemRadiological Imaging Technology, Inc. · 1994
This deviceK040709 Protos SoftwareAktina Medical Physics Corp. · 2004

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K935928	Rit 113 Film Analysis System	Radiological Imaging Technology, Inc.	1994	—
0 (this device)	K040709	Protos Software	Aktina Medical Physics Corp.	2004	—

FIG. 1 — Lineage of K040709, 1994–2004Source: 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
*	K935928	Rit 113 Film Analysis System Summary page 1 …Registration Number: 2436865 2. Name of Predicate Device Radiological Imaging Technology, Inc., RIT 113 Film Analysis System, K935928 Any statement made in conjunction with this submission regarding substantial equivalence to any other p…	Radiological Imaging Technology, Inc.	1994	—

Also cleared against K935928: 5 other devices →

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.

What does this lineage say?

Its one ancestor has no recall.
5 other devices also cite its predicate K935928.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

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?

External Beam Radiation Therapy is typically delivered to patients from a linear accelerator with either photon or electron beams, or from a radioactive source (high and low dose rate variants). AKTINA Medical Physics Corporation has designed and manufactured software to aid in the verification of the delivery prior to radiotherapy treatment. The software analyzes and compares the predicted data from a treatment planning computer to measured data from delivered dose measurements.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K040709 · printed Nov 3, 2026

Cite this page

510(k) Report. “K040709: Protos Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K040709

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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