510(k) Report

510(k) · Cleared

Cleared

Radiation Beam Data Acquistioin Systems

K854880510(k) TraditionalCleared Jan 10, 198635-day reviewClass II21 CFR 892.5840

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

Computerized Medical Systems, Inc. · KPQ System, Simulation, Radiation Therapy

Cleared on Jan 10, 1986 after a 35-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.

Decided
Jan 10, 1986
Review
35 days
Class
Class II
Product code
KPQ
Recalls
None
Predicates
0

2 later devices descend from it, 1 citing it directly.

Descendants, by year cleared 2010: 1 descendant cleared2024: 1 descendant cleared1990200020102020
  1. This deviceK854880 Radiation Beam Data Acquistioin SystemsComputerized Medical Systems, Inc. · 1986
  2. Descendant · cites it directly · 1 of its ownK103193 Doseview 3DStandard Imaging, Inc. · 2010
  3. Descendant · 2 generations on · 0 of its ownK232738 BeamDose software (S080053); BEAMSCAN software, option reference…Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2024

Most influential descendants

Showing 2 of 2 · See all
  • K103193Doseview 3DStandard Imaging, Inc. · 2010 · cites it directly1descendant
  • K232738BeamDose software (S080053); BEAMSCAN software, option reference dosimetry (S080054.002)Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla · 2024 · 2 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K854880Radiation Beam Data Acquistioin SystemsComputerized Medical Systems, Inc.1986—
+1K103193Doseview 3DStandard Imaging, Inc.2010—
+2K232738BeamDose software (S080053); BEAMSCAN software, option reference dosimetry…Ptw-Freiburg Physikalisch-Technische-Werkstaetten Dr. Pychla2024—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201010
202410
FIG. 1 — Lineage of K854880, 1986–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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.

Planning a device in KPQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

  • Candidate predicates for a device like this, rankedin the report
  • Recall history across each candidate’s familyin the report
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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? (2)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K103193Doseview 3DStandard Imaging, Inc.20101

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, K103193 (Standard Imaging, Inc., 2010) has gone furthest, with 1 descendant of its own.

How does its category compare?

All KPQ devices

KPQ System, Simulation, Radiation Therapy: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KPQ

1in 2014

2007: 12008: 12009: 12010: 12013: 12014: 1
2007high 1 (2007) · low 0 (2011)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KPQ

Too few KPQ 510(k)s in any year since 2007 to give a median.

Recalls per year · KPQ

1in 2014

2007: 62008: 32009: 12012: 12013: 12014: 1
2007high 6 (2007) · low 0 (2010)2026

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

Adverse event reports per year · KPQ

1in 2020

2007: 172008: 122009: 72010: 102011: 122012: 112013: 12014: 32019: 12020: 1
2007high 17 (2007) · low 0 (2015)2025

MAUDE reports naming product code KPQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071—617
20081—312
20091—17
20101—010
20110—012
20120—111
20131—11
20141—13
20150—00
20160—00
20170—00
20180—00
20190—01
20200—01
20210—00
20220—00
20230—00
20240—00
20250—00
20260—0—

More from Computerized Medical Systems, Inc.

23 FDA decisions under this applicant name. See the company

  • K110730Monaco RTP SystemComputerized Medical Systems, Inc. · 20116 recalls
  • K102216Xio RTP SystemComputerized Medical Systems, Inc. · 20107 recalls
  • K092132Xio RTP SystemComputerized Medical Systems, Inc. · 200912 recalls
  • K091179Monaco RTP System, Vmat OptionComputerized Medical Systems, Inc. · 20095 recalls
  • K080799Atlas-Based AutosegmentationComputerized Medical Systems, Inc. · 2008

Recent decisions in KPQ

The KPQ category page

  • K132944Advantagesim MD MR Pelvic Organ at Risk SegmentationGe Hungary Kft · 2014
  • K132045Advantagesim MD with CT Atlas-Based Contouring and RE-Planning OptionsGe Hungary Kft · 2013
  • K101038Rad II Simulator, Rad II KV Imager, Dual Rad II KV ImagerAcceletronics Digital Imaging, LLC · 2010
  • K090706Oncentra Simulation 2.3Nucletron Corporation · 2009
  • K083591Ikoengelo, Version 2Ikoetech, LLC · 2008

https://510kreport.com/device/K854880 · printed Nov 4, 2026

Cite this page

510(k) Report. “K854880: Radiation Beam Data Acquistioin Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K854880

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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