510(k) · Cleared

Recalled · 2008

Preciseplan 2.0

K022411510(k) TraditionalCleared Sep 20, 200258-day reviewClass II21 CFR 892.5050Recalls 4

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

Precision Therapy Intl., Inc. · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Sep 20, 2002 as substantially equivalent to K002240 (Precision Therapy Intl., Inc., 2000) after a 58-day review. Its family tree reaches back 1 generation to 2000. It has been recalled 4 times.

Decided: Sep 20, 2002
Review: 58 days
Class: Class II
Product code: MUJ
Recalls: 4
Predicates: 1

Its longest line of descent runs back 1 generation to K002240 (2000). No later device cites it as a predicate yet.

By dateBy generation

Root · 1 generation backK002240 Render-Plan 3-D 4.00 & Precise-Plan 1.0Precision Therapy Intl., Inc. · 2000
This deviceK022411 Preciseplan 2.0Precision Therapy Intl., Inc. · 2002

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002240	Render-Plan 3-D 4.00 & Precise-Plan 1.0	Precision Therapy Intl., Inc.	2000	—
0 (this device)	K022411	Preciseplan 2.0	Precision Therapy Intl., Inc.	2002	—

FIG. 1 — Lineage of K022411, 2000–2002Source: 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
*	K002240	Render-Plan 3-D 4.00 & Precise-Plan 1.0	Precision Therapy Intl., Inc.	2000	—

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Sep 30, 2008	Not classified	Z-1109-2010	Other	The new "DICOM CT with Body Outline" method to create a patient case in PrecisePLAN 2.15 may produce incorrect results for some customers, given several input conditions encountered in the field. Discontinue use of this method of creating…
Feb 5, 2008	Not classified	Z-1556-2011	Other	When using the 'Beam Edit" function to modify a bean in an unlocked Fraction Group, there are two conditions that may cause the user to unitentionally modify a locked fraction group.
Jan 28, 2008	Not classified	Z-1476-2011	Other	PrecisePLAN generates digitally Reconstructed Radiographs (DRR;s) with a shift in the superior direction.
Mar 15, 2006	Not classified	Z-1406-2010	Software design	Error in dose rates which were calculated at exactly twice the expected values.

No ancestor or descendant has a Class I recall.

What does this lineage say?

Its one ancestor has no 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?

Read the full statement (104 words)

The PrecisePLAP Treatment Planning System is intended to be used for planning the dosimetry of treatments in radiation therapy. PrecisePLAP provides 2 and 3 dimensional planning capabilities based upon user defined treatment plan parameters. As an option, the user may elect to use weight optimization functionality that suports Intensity Modulated Radiaton Therapy (IMRT). Using the IMRT functionality extends the 3-D conformal planning where geometric shaped apertures are created to cover target structure(s) and minimize exposure to surrounding organs at risk. It processes the inputs of the health care professional such that the desired radiation dose can be set on a radiation therapy delivery system.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K022411 · printed Nov 6, 2026

Cite this page

510(k) Report. “K022411: Preciseplan 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K022411

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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