510(k) Report

510(k) · Cleared

Cleared

Focus RTP System

K973936510(k) TraditionalCleared Jun 1, 1998229-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

Computerized Medical Systems, Inc. · IYE Accelerator, Linear, Medical

Cleared on Jun 1, 1998 as substantially equivalent to K951581 (Adac Laboratories, 1996) and 2 other predicates after a 229-day review. Its family tree reaches back 2 generations to 1989. 1 later device descends from it.

Decided
Jun 1, 1998
Review
229 days
Class
Class II
Product code
IYE
Recalls
None
Predicates
3

Its longest line of descent runs back 2 generations to K894706 (1989). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 1995: 2 other ancestors1994: 1 other ancestor1990: 1 other ancestor2009: 1 descendant clearedK894706 · HT-Res RTP System · Adac Laboratories · 1989K951581 · PINNACLE3 Apex · Adac Laboratories · 19961990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 2 other ancestors 1 generation forward: 1 descendant K951581 · PINNACLE3 Apex · Adac Laboratories · 1996K894706 · HT-Res RTP System · Adac Laboratories · 19890
  1. Root · 2 generations backK894706 HT-Res RTP SystemAdac Laboratories · 1989
  2. 1 generation backK951581 PINNACLE3 ApexAdac Laboratories · 1996
  3. This deviceK973936 Focus RTP SystemComputerized Medical Systems, Inc. · 1998
  4. Descendant · cites it directly · 0 of its ownK090182 Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009

Most influential descendants

Showing 1 of 1 · See all
  • K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K894706HT-Res RTP SystemAdac Laboratories1989—
−1K951581PINNACLE3 ApexAdac Laboratories1996—
0 (this device)K973936Focus RTP SystemComputerized Medical Systems, Inc.1998—
+1K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.2009—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199410
199520

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200910
FIG. 1 — Lineage of K973936, 1989–2009Source: 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), 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 IYE? 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 IYE device

  1. #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K951581PINNACLE3 Apex
Summary page 1
…Radiation Treatment Planning System System, Simulator, Radiation Therapy per 21 CFR 892.5840 (Class II) ADAC Pinnacle’ APEX Stereotactic Radiosurgery Planning System - K951581 Nucletron PLATO SRS Stereotactic Radiosurgery System - K940001 RSA XKNIFE3 Stereotactic Radiosurgery System - K953482 Device D…
Adac Laboratories1996—
*K940001Plato-SRS (Stereo Radiosurgery Treatment Planning Sys)
Summary page 1
…n Therapy per 21 CFR 892.5840 (Class II) ADAC Pinnacle’ APEX Stereotactic Radiosurgery Planning System - K951581 Nucletron PLATO SRS Stereotactic Radiosurgery System - K940001 RSA XKNIFE3 Stereotactic Radiosurgery System - K953482 Device Description: The FOCUS Radiation Treatment Planning System accept…
Nucletron Corp.1995—
*K953482Xknife-3
Summary page 1
…APEX Stereotactic Radiosurgery Planning System - K951581 Nucletron PLATO SRS Stereotactic Radiosurgery System - K940001 RSA XKNIFE3 Stereotactic Radiosurgery System - K953482 Device Description: The FOCUS Radiation Treatment Planning System accepts a) patient diagnostic imaging data from CT or MR scans…
Radionics Software Applications, Inc.1995—

Also cleared against K951581: 4 other devices →

What descends from it? (1)

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

NumberDeviceApplicantDecidedDescendants
K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A.20090

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 9 years and passes through 2 companies; a new generation was cleared every 6.5 years on median.
  • None of the 6 ancestors has a recall.
  • Of its descendants, K090182 (Nuclemed S.A., 2009) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K951581.

How does its category compare?

All IYE devices

IYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · IYE

12in 2025

2007: 232008: 142009: 202010: 232011: 112012: 282013: 182014: 202015: 202016: 212017: 232018: 212019: 192020: 202021: 192022: 122023: 182024: 92025: 122026 (partial year): 14
2007high 28 (2012) · low 9 (2024)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · IYE

170in 2025

2007: 44 days median2008: 69 days median2009: 63 days median2010: 74 days median2011: 94 days median2012: 106 days median2013: 88 days median2014: 100 days median2015: 108 days median2016: 97 days median2017: 94 days median2018: 58 days median2019: 83 days median2020: 67 days median2021: 86 days median2022: 172 days median2023: 129 days median2024: 239 days median2025: 170 days median2026 (partial year): 120 days median
2007high 239 (2024) · low 44 (2007)2026

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

Recalls per year · IYE

1in 2025

2007: 782008: 492009: 222010: 272011: 732012: 202013: 112014: 142015: 82016: 72017: 72018: 72019: 22020: 42021: 52022: 32023: 72024: 12025: 12026 (partial year): 4
2007high 78 (2007) · low 1 (2024)2026

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

Adverse event reports per year · IYE

101in 2025

2007: 1552008: 1142009: 1742010: 2462011: 2802012: 1282013: 962014: 1242015: 1002016: 972017: 1252018: 852019: 912020: 742021: 682022: 662023: 1282024: 812025: 101
2007high 280 (2011) · low 66 (2022)2025

MAUDE reports naming product code IYE, 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
2007234478155
2008146949114
2009206322174
2010237427246
2011119473280
20122810620128
201318881196
20142010014124
2015201088100
20162197797
201723947125
20182158785
20191983291
20202067474
20211986568
202212172366
2023181297128
20249239181
2025121701101
2026141204—

What is it indicated for?

To calculate and display, both on-screen and in hard-copy, either two- or three-dimensional radiation dose distributions within a patient diagnosed as having single or multiple brain lesions based on user-defined radiation treatment plan parameters.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K951581

4 other devices cite the same predicate.

  • K090182Module Integrated Radiotherapy System (Mirs)Nuclemed S.A. · 2009
  • K040688Standard Imaging E.Imrt CalculatorStandard Imaging, Inc. · 2004
  • K993923Adac PINNACLE3TM Radiation Therapy Planning SystemAdac Laboratories · 2000
  • K964206Nucletron Plato External Beam Planning RTS V2 and RTS 3D V2Nucletron Corp. · 1997

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 IYE

The IYE category page

  • K261865AerFrame™ Alignment Laser Box (LBV2)Stabilix, LLC · 2026
  • K261718EZFluence (RADEZ V2)Radformation, Inc. · 2026
  • K260733MRIA Radiation Therapy Information System (MRIA)Manteia Technologies Co., Ltd. · 2026
  • K261856Halcyon, Ethos Radiotherapy System (5.0)Varian Medical Systems, Inc. · 2026
  • K252937ThinkQA 3Dosisoft SA · 2026

https://510kreport.com/device/K973936 · printed Nov 6, 2026

Cite this page

510(k) Report. “K973936: Focus RTP System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K973936

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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