510(k) · Cleared

Cleared

Omnidos

K011763510(k) TraditionalCleared Sep 5, 200190-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

Scanditronix Medical AB · IYE Accelerator, Linear, Medical

Cleared on Sep 5, 2001 as substantially equivalent to K945321 (Medical Physics Instrumentation, Inc., 1995) and 2 other predicates after a 90-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.

Decided: Sep 5, 2001
Review: 90 days
Class: Class II
Product code: IYE
Recalls: None
Predicates: 3

Its longest line of descent runs back 2 generations to K934303 (1994). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 2 generations backK934303 RFA A-300Scanditronix, Inc. · 1994
1 generation backK961400 Rfa-300, Lda UtilityScanditronix Medical AB · 1997
This deviceK011763 OmnidosScanditronix Medical AB · 2001
Descendant · cites it directly · 0 of its ownK092018 Omnipro InclineIba Dosimetry GmbH · 2009

Most influential descendants

Showing 1 of 1 · See all

K092018Omnipro InclineIba Dosimetry GmbH · 2009 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K934303	RFA A-300	Scanditronix, Inc.	1994	—
−1	K961400	Rfa-300, Lda Utility	Scanditronix Medical AB	1997	—
0 (this device)	K011763	Omnidos	Scanditronix Medical AB	2001	—
+1	K092018	Omnipro Incline	Iba Dosimetry GmbH	2009	—

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1995	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0

FIG. 1 — Lineage of K011763, 1994–2009Source: 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

Get a 510(k) Report

What was it cleared against? (3)

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
*	K945321	Wellhofer WP700 V. 3.2 Summary page 1 …therapy system, §892,5750; X-ray radiation therapy system, §892,5900; and Medical charged-particle radiation therapy system, §892.5050. WP700 (Wellhsfer Dosimetrie) FDA K945321/S1, 1995, 29" of March. RFA-300 (Scanditronix Medical) FDA K934303/S1, 510(k) Aug 1994, RFA-300, LDA Utility (Scanditronix Medi…	Medical Physics Instrumentation, Inc.	1995	2
*	K934303	RFA A-300 Summary page 1 …; and Medical charged-particle radiation therapy system, §892.5050. WP700 (Wellhsfer Dosimetrie) FDA K945321/S1, 1995, 29" of March. RFA-300 (Scanditronix Medical) FDA K934303/S1, 510(k) Aug 1994, RFA-300, LDA Utility (Scanditronix Medical) FDA K961400: Jan. 1997 ‘The Scanditronix & Wellhéfer OmniDos i…	Scanditronix, Inc.	1994	—
*	K961400	Rfa-300, Lda Utility Summary page 1 …llhsfer Dosimetrie) FDA K945321/S1, 1995, 29" of March. RFA-300 (Scanditronix Medical) FDA K934303/S1, 510(k) Aug 1994, RFA-300, LDA Utility (Scanditronix Medical) FDA K961400: Jan. 1997 ‘The Scanditronix & Wellhéfer OmniDos is a General Dosimetry ~Systenr similar to Wellhsfer Dosimetrie: WP700, FDA K…	Scanditronix Medical AB	1997	—

Also cleared against K945321: 1 other device →

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
K092018	Omnipro Incline	Iba Dosimetry GmbH	2009	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?

The line of descent spans 7 years and passes through 2 companies; a new generation was cleared every 4.7 years on median.
1 of the 3 ancestors has a recall of any class.
Of its descendants, K092018 (Iba Dosimetry GmbH, 2009) has gone furthest, with 0 descendants of its own.
1 other device also cites its predicate K945321.

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?

OmniDos is a system software utilising hardware components to measure radiation dose distribution. The hardware consists of water phantoms, air scanners, film scanners/ digitizers and single or array detectors. The hardware comes from Scanditronix Medical, the sister company Wellhofer Dosimetry and from 3rd party vendors.

OmniDos is used to accurately analyse and handle the measured dose distribution in quality assurance purposes, for calibration of radiation devices, as input data to Treatment Planning Systems, for acceptance testing, beam tuning and in research.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

https://510kreport.com/device/K011763 · printed Nov 5, 2026

Cite this page

510(k) Report. “K011763: Omnidos.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K011763

Report an extraction error

Are you the manufacturer?

Record history

FDA decision record loaded May 2, 2026
Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
Lineage and recalls computed Nov 3, 2026
Page last updated Nov 3, 2026