510(k) · Cleared

Cleared

Rocs TPS

K982791510(k) TraditionalCleared Dec 30, 1998142-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

Radiation Oncology Computer Systems · MUJ System, Planning, Radiation Therapy Treatment

Cleared on Dec 30, 1998 as substantially equivalent to K862643 (Pacific Physics, Inc., 1987) after a 142-day review. Its family tree reaches back 1 generation to 1987. 1 later device descends from it.

Decided: Dec 30, 1998
Review: 142 days
Class: Class II
Product code: MUJ
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K862643 (1987). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
This deviceK982791 Rocs TPSRadiation Oncology Computer Systems · 1998
Descendant · cites it directly · 0 of its ownK993359 Raptor Treatment Planning SystemNomos Corp. · 1999

Most influential descendants

Showing 1 of 1 · See all

K993359Raptor Treatment Planning SystemNomos Corp. · 1999 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K862643	Radiation Oncology Computer Sys Treatment Planning	Pacific Physics, Inc.	1987	—
0 (this device)	K982791	Rocs TPS	Radiation Oncology Computer Systems	1998	—
+1	K993359	Raptor Treatment Planning System	Nomos Corp.	1999	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
1999	1	0

FIG. 1 — Lineage of K982791, 1987–1999Source: 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
*	K862643	Radiation Oncology Computer Sys Treatment Planning Summary page 1 …: Accelerator, Linear, Medical, Accessory Number: 90 IYE (892.5050) Predicate Device: Radiation Oncology Computer Systems Treatment Planning System 510(k) notification K862643 Device Description: ROCS treatment planning system is a collection of software modules that execute well known and documented a…	Pacific Physics, Inc.	1987	—

Also cleared against K862643: 3 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
K993359	Raptor Treatment Planning System	Nomos Corp.	1999	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, K993359 (Nomos Corp., 1999) has gone furthest, with 0 descendants of its own.
3 other devices also cite its predicate K862643.

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?

ROCS TPS (Radiation Therapy Treatment Planning System) is intended to be used for the computation, display, evaluation and output documentation of radiation dose estimations to be submitted for independent clinical review and judgment prior to use. The device provides output data in the form of displays, hardcopy prints and/or plots to guide a physician in selecting the optimum patient treatment plan. It is intended to provide a report to be used by a competent health professional such as a radiation oncologist, medical physicist, radiation therapist or dosimetrist

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/K982791 · printed Nov 4, 2026

Cite this page

510(k) Report. “K982791: Rocs TPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982791

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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