510(k) · Cleared
ClearedFocus Radiation Treatment Planning System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Computerized Medical Systems, Inc. · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Oct 8, 2002 as substantially equivalent to K000922 (Varian Assoc., Inc., 2000) after a 277-day review. Its family tree reaches back 1 generation to 2000.
- Decided
- Oct 8, 2002
- Review
- 277 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K000922 (2000). No later device cites it as a predicate yet.
- Root · 1 generation backK000922 Proton VisionVarian Assoc., Inc. · 2000
- This deviceK020027 Focus Radiation Treatment Planning SystemComputerized Medical Systems, Inc. · 2002
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K000922 | Proton Vision | Varian Assoc., Inc. | 2000 | — |
| 0 (this device) | K020027 | Focus Radiation Treatment Planning System | Computerized Medical Systems, Inc. | 2002 | — |
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
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 | Decided |
|---|---|---|---|
| * | K000922 | Proton Vision | 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)
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.
- 2 other devices also cite its predicate K000922.
How does its category compare?
All MUJ devicesMUJ System, Planning, Radiation Therapy Treatment: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MUJ
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MUJ
186in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MUJ
2in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MUJ
21in 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?
The FOCUS RTP System consists of CMS-developed software running on UNIX-based operating systems and off the shelf hardware including computers and various computer peripherals (digitizing tablet, printed plotter, etc.). The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be…
Read the full statement (118 words)
The FOCUS RTP System consists of CMS-developed software running on UNIX-based operating systems and off the shelf hardware including computers and various computer peripherals (digitizing tablet, printed plotter, etc.).
The intended use of FOCUS RTP System is to provide radiation treatment planning capability, for both external beam and brachytherapy sources, to satisfy the prescription of a Radiation Oncologist. The resultant treatment plan is to be evaluated, modified as necessary, approved and delivered by qualified medical personnel. Operation of the system is identical to FOCUS systems cleared under previous Premarket Notifications with the exception the user can now select a third type of external beam particle for therapy (protons) in addition to the earlier two particles (electrons and photons).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020027: Focus Radiation Treatment Planning System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020027
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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