510(k) · Cleared

Cleared

Integra Radionics Imagefusion 3

K063230510(k) SpecialCleared Dec 21, 200657-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

Integra Radionics, Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Dec 21, 2006 as substantially equivalent to K990071 (Radionics, Inc., 1999) after a 57-day review. Its family tree reaches back 2 generations to 1996.

Decided: Dec 21, 2006
Review: 57 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K960071 (1996). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK960071 ImagefusionRadionics Software Applications, Inc. · 1996
1 generation backK990071 Imagefusion 2.0Radionics, Inc. · 1999
This deviceK063230 Integra Radionics Imagefusion 3Integra Radionics, Inc. · 2006

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K960071	Imagefusion	Radionics Software Applications, Inc.	1996	—
−1	K990071	Imagefusion 2.0	Radionics, Inc.	1999	—
0 (this device)	K063230	Integra Radionics Imagefusion 3	Integra Radionics, Inc.	2006	—

FIG. 1 — Lineage of K063230, 1996–2006Source: 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 MUJ? 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 MUJ device

#1 K232799 syngo.via RT Image Suitescore 18.6 · 19 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
*	K990071	Imagefusion 2.0 Summary page 1 …lassification name is Medical charged-particle radiation therapy system. 3.0 The above device is substantial equivalent to the Radionics ImageFusion 2, 510(k), K990071 4.0 The above system is a pre-processing registration (fusion) software for CT, MR and PET scans. The software provides QA t…	Radionics, Inc.	1999	—

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?

The line of descent spans 10 years and passes through 3 companies; a new generation was cleared every 7.9 years on median.
None of the 2 ancestors has a recall.

How does its category compare?

All MUJ devices

MUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · MUJ

10in 2025

2007high 16 (2009) · low 4 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MUJ

186in 2025

2007high 233 (2026) · low 30 (2017)2026

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

Recalls per year · MUJ

2in 2023

2007high 23 (2010) · low 0 (2024)2026

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

Adverse event reports per year · MUJ

21in 2025

2007high 78 (2010) · low 9 (2024)2025

MAUDE reports naming product code MUJ, 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	4	67	4	24
2008	9	63	10	51
2009	16	84	11	24
2010	11	56	23	78
2011	9	103	17	73
2012	8	59	4	39
2013	5	64	6	33
2014	9	108	2	35
2015	13	78	7	30
2016	5	80	13	27
2017	7	30	4	16
2018	7	53	3	25
2019	9	56	4	25
2020	9	104	2	26
2021	11	87	4	15
2022	8	168	3	22
2023	10	140	2	76
2024	9	122	0	9
2025	10	186	0	21
2026	9	233	2	—

What is it indicated for?

A pre-processing registration tool for use with other stereotactic surgical and neurosurgical treatment planning systems

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K063230 · printed Nov 4, 2026

Cite this page

510(k) Report. “K063230: Integra Radionics Imagefusion 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063230

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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