510(k) · Cleared
ClearedMultidos, QC6PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-New York Corp. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Sep 10, 1997 as substantially equivalent to K954165 (Ptw-New York Corp., 1995) and 2 other predicates after a 90-day review. Its family tree reaches back 1 generation to 1988. 34 later devices descend from it.
- Decided
- Sep 10, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K874893 (1988). 3 ancestors in all. 34 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK874893 Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc. · 1988
- This deviceK972211 Multidos, QC6PLUSPtw-New York Corp. · 1997
- Descendant · cites it directly · 33 of its ownK062817 PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
- Descendant · 2 generations on · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- Descendant · 3 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · 4 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 5 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
Showing 5 of 34 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 34 · See all- K062817PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006 · cites it directly33descendants
- K072374CompassScanditronix Wellhofer GmbH · 2007 · 2 generations on31descendants
- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 3 generations on23descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 4 generations on13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 5 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K874893 | Model 35300 Tracker (TM) Therapy Beam Evaluator | Keithley Instruments, Inc. | 1988 | — |
| 0 (this device) | K972211 | Multidos, QC6PLUS | Ptw-New York Corp. | 1997 | — |
| +1 | K062817 | PTW David Imrt QC Verification System | Ptw-New York Corp. | 2006 | — |
| +2 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| +3 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +4 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +5 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 6 | 0 |
| 2017 | 3 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 LHN? 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 LHN device
- #1 K260597 Virtue QAscore 15.4 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K954165 | PTW-MP3 & PTW-MP3S Automatic Water PhantomSummary page 1…mon/Usual Name: Muitiple channel electrometer, Therapy beam constancy check device. Predicate Device(s): MULTIDOS: PTW T10006, MULTIDOS ME48, 48 channel electrometer, K954165, and Nuclear Associates, 37-702 and 37-703, PC Rainbow, K900932. QC6PLUS: Keithley 35300, Tracker™, Therapy Beam Evaluation Syst… | 1995 |
| * | K900932 | 37-702 and 37-703 PC RainbowSummary page 1…stancy check device. Predicate Device(s): MULTIDOS: PTW T10006, MULTIDOS ME48, 48 channel electrometer, K954165, and Nuclear Associates, 37-702 and 37-703, PC Rainbow, K900932. QC6PLUS: Keithley 35300, Tracker™, Therapy Beam Evaluation System, K874893 Description of Device(s;: The PTW T10004 MULTIDOS… | 1990 |
| * | K874893 | Model 35300 Tracker (TM) Therapy Beam EvaluatorSummary page 1…48, 48 channel electrometer, K954165, and Nuclear Associates, 37-702 and 37-703, PC Rainbow, K900932. QC6PLUS: Keithley 35300, Tracker™, Therapy Beam Evaluation System, K874893 Description of Device(s;: The PTW T10004 MULTIDOS is a field class multiple-purpose multiple-channel electrometer. This device… | 1988 |
What descends from it? (34)
See all 341 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062817 | PTW David Imrt QC Verification System | 2006 | 33 |
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?
How does its category compare?
All LHN devicesLHN System, Radiation Therapy, Charged-Particle, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHN
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHN
190in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHN
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LHN
11in 2025
MAUDE reports naming product code LHN, 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 | 2 | — | 2 | 0 |
| 2008 | 3 | 113 | 2 | 1 |
| 2009 | 5 | 69 | 0 | 5 |
| 2010 | 4 | 96 | 0 | 3 |
| 2011 | 1 | — | 0 | 1 |
| 2012 | 3 | 111 | 0 | 1 |
| 2013 | 3 | 70 | 0 | 1 |
| 2014 | 4 | 93 | 2 | 5 |
| 2015 | 3 | 53 | 1 | 2 |
| 2016 | 7 | 120 | 0 | 1 |
| 2017 | 4 | 173 | 5 | 7 |
| 2018 | 3 | 78 | 2 | 8 |
| 2019 | 2 | — | 0 | 3 |
| 2020 | 4 | 74 | 1 | 20 |
| 2021 | 0 | — | 1 | 24 |
| 2022 | 2 | — | 2 | 10 |
| 2023 | 2 | — | 1 | 7 |
| 2024 | 1 | — | 0 | 2 |
| 2025 | 3 | 190 | 0 | 11 |
| 2026 | 4 | 194 | 0 | — |
What is it indicated for?
The PTW T10004 MULTIDOS is a multiple-purpose, multiple-channel electrometer intended to perform a range of measuring tasks in radiation therapy. As a stand alone dosemeter, MULTIDOS is intended to be used to measure the dose delivered to a patient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors and are used to compare and to verify treatment dose…
Read the full statement (183 words)
The PTW T10004 MULTIDOS is a multiple-purpose, multiple-channel electrometer intended to perform a range of measuring tasks in radiation therapy. As a stand alone dosemeter, MULTIDOS is intended to be used to measure the dose delivered to a patient during a radiation therapy treatment. Dose measurements during treatment may be accomplished by using suitable ionization chambers or solid state detectors and are used to compare and to verify treatment dose to prescribed dose.
When connected to the optional QC6PLUS, MULTIDOS is intended to be used to measure the beam characteristics of radiation therapy treatment machines. Data acquired with the MULTIDOS and the QC6PLUS is used to compile radiation beam data over time as part of a quality assurance program.
High quality dosimetry devices like the PTW T10004 MULTIDOS and the optional T42007 QC6PLUS make it possible to routinely measure, record, document and verify therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision. High quality multiple purpose dosimetry devices are essential if accurate data from treatment machines that produce therapeutic amounts of ionizing radiation are to be properly monitored.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972211 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972211: Multidos, QC6PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972211
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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