510(k) · Cleared
ClearedTigrt TPS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Linatech, LLC · MUJ System, Planning, Radiation Therapy Treatment
Cleared on Jul 15, 2009 as substantially equivalent to K041971 (Prodigm Group, Inc., 2005) after a 106-day review. Its family tree reaches back 4 generations to 1989.
- Decided
- Jul 15, 2009
- Review
- 106 days
- Class
- Class II
- Product code
- MUJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K884261 (1989). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK884261 Prowess 2000Small Systems Group, Inc. · 1989
- 3 generations backK940663 Peacock PlanNomos Corp. · 1996
- 2 generations backK984532 Cadplan Helios Option 6.0Varian Medical Systems, Inc. · 1999
- 1 generation backK041971 Wimrt Module for Artp Planning SystemProdigm Group, Inc. · 2005
- This deviceK090893 Tigrt TPSLinatech, LLC · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K884261 | Prowess 2000 | Small Systems Group, Inc. | 1989 | — |
| −3 | K940663 | Peacock Plan | Nomos Corp. | 1996 | — |
| −2 | K984532 | Cadplan Helios Option 6.0 | Varian Medical Systems, Inc. | 1999 | — |
| −1 | K041971 | Wimrt Module for Artp Planning System | Prodigm Group, Inc. | 2005 | — |
| 0 (this device) | K090893 | Tigrt TPS | Linatech, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 2001 | 1 | 0 |
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 |
|---|---|---|---|
| * | K041971 | Wimrt Module for Artp Planning SystemSummary page 1…e Device Identification 21 CFR 892.5050 Radiation Treatment Planning System Product Code: MUJ Device Class: II 3. Legally Marketed Equivalent Device WIMRT (K041971) 4. Intended Use and Device Description TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose plan… | 2005 |
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?
- The line of descent spans 20 years and passes through 5 companies; a new generation was cleared every 5.8 years on median.
- None of the 7 ancestors has a recall.
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. 2009, this device’s year, is highlighted.
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?
TiGRT TPS is a Radiation Therapy Treatment Planning System for radiation dose planning of patients undergoing external beam treatment in the oncology clinic. TiGRT TPS is used to plan radiation treatments with linear accelerators and other similar teletherapy devices with x-ray and/or electron energies from 1 to 25MV, as well as Cobalt-60.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090893 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090893: Tigrt TPS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090893
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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