510(k) Report

510(k) · Cleared

Cleared

Radiation Oncology Computer Sys Treatment Planning

K862643510(k) TraditionalCleared Mar 9, 1987241-day review

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

Pacific Physics, Inc.

Cleared on Mar 9, 1987 after a 241-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 68 later devices descend from it.

Decided
Mar 9, 1987
Review
241 days
Recalls
None
Predicates
0

68 later devices descend from it, 4 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared1998: 3 descendants cleared1999: 2 descendants cleared2003: 2 descendants cleared2000: 1 descendant cleared2008: 2 descendants cleared2007: 1 descendant cleared2009: 3 descendants cleared2012: 3 descendants cleared2010: 4 descendants cleared2011: 1 descendant cleared2013: 3 descendants cleared2014: 4 descendants cleared2020: 3 descendants cleared2015: 3 descendants cleared2016: 3 descendants cleared2017: 5 descendants cleared2018: 5 descendants cleared2023: 3 descendants cleared2019: 4 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2022: 4 descendants cleared2026: 1 descendant cleared2025: 2 descendants cleared1990200020102020
  1. This deviceK862643 Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc. · 1987
  2. Descendant · cites it directly · 65 of its ownK970236 Theraplan Plus Version 1.2Theratronics, Inc. · 1997
  3. Descendant · 2 generations on · 59 of its ownK031349 OTP 1.2Nucletron Corp. · 2003
  4. Descendant · 3 generations on · 54 of its ownK081281 Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · Recalled
  5. Descendant · 4 generations on · 34 of its ownK092132 Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · Recalled
  6. Descendant · 4 generations on · 31 of its ownK083264 Rayautoplan 1.0Raysearch Laboratories AB · 2009 · Recalled

Showing 5 of 68 descendants. See all descendants

Descendants cleared per year

1997: 11998: 31999: 22000: 12003: 22007: 12008: 22009: 32010: 42011: 12012: 32013: 32014: 42015: 32016: 32017: 52018: 52019: 42020: 32021: 32022: 42023: 32024: 22025: 22026: 1
1997high 5 (2017) · low 0 (2001)2026

Most influential descendants

Showing 5 of 68 · See all
  • K970236Theraplan Plus Version 1.2Theratronics, Inc. · 1997 · cites it directly65descendants
  • K031349OTP 1.2Nucletron Corp. · 2003 · 2 generations on59descendants
  • K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation · 2008 · 3 generations on54descendants
  • K092132Xio RTP SystemComputerized Medical Systems, Inc. · 2009 · 4 generations on34descendants
  • K083264Rayautoplan 1.0Raysearch Laboratories AB · 2009 · 4 generations on31descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K862643Radiation Oncology Computer Sys Treatment PlanningPacific Physics, Inc.1987—
+1K970236Theraplan Plus Version 1.2Theratronics, Inc.1997—
+2K031349OTP 1.2Nucletron Corp.2003—
+3K081281Ocentra Masterplan 3.1 (Ocentra Brachy)Nucletron Corporation20082
+4K092132Xio RTP SystemComputerized Medical Systems, Inc.200912
+4K083264Rayautoplan 1.0Raysearch Laboratories AB20092

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199830
199920
200010
200320
200710
200820
200930
201040
201110
201230
201330
201440
201530
201630
201750
201850
201940
202030
202130
202240
202330
202420
202520
202610
FIG. 1 — Lineage of K862643, 1987–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

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What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (68)

See all 68

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K970236Theraplan Plus Version 1.2Theratronics, Inc.199765
K980379Prowess Pro-SimSsgi Prowess Systems19983
K982791Rocs TPSRadiation Oncology Computer Systems19981
K984241Rocs UltraseedRadiation Oncology Computer Systems19990

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?

  • Of its descendants, K970236 (Theratronics, Inc., 1997) has gone furthest, with 65 descendants of its own.

https://510kreport.com/device/K862643 · printed Nov 6, 2026

Cite this page

510(k) Report. “K862643: Radiation Oncology Computer Sys Treatment Planning.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K862643

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Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026