510(k) · Cleared
ClearedPTW David Imrt QC Verification System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ptw-New York Corp. · IYE Accelerator, Linear, Medical
Cleared on Nov 22, 2006 as substantially equivalent to K972211 (Ptw-New York Corp., 1997) after a 63-day review. Its family tree reaches back 2 generations to 1988. 33 later devices descend from it.
- Decided
- Nov 22, 2006
- Review
- 63 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K874893 (1988). 4 ancestors in all. 33 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK874893 Model 35300 Tracker (TM) Therapy Beam EvaluatorKeithley Instruments, Inc. · 1988
- 1 generation backK972211 Multidos, QC6PLUSPtw-New York Corp. · 1997
- This deviceK062817 PTW David Imrt QC Verification SystemPtw-New York Corp. · 2006
- Descendant · cites it directly · 31 of its ownK072374 CompassScanditronix Wellhofer GmbH · 2007 · Recalled
- Descendant · 2 generations on · 23 of its ownK140660 MOBIUS3DMobius Medical Systems, LP · 2014 · Recalled
- Descendant · 3 generations on · 13 of its ownK153014 Mobius3DMobius Medical Systems, LP · 2016
- Descendant · 4 generations on · 5 of its ownK191761 Mobius3DVarian Medical Systems, Inc. · 2019
- Descendant · 2 generations on · 5 of its ownK141800 PerfractionSun Nuclear Corporation · 2014
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K072374CompassScanditronix Wellhofer GmbH · 2007 · cites it directly31descendants
- K140660MOBIUS3DMobius Medical Systems, LP · 2014 · 2 generations on23descendants
- K153014Mobius3DMobius Medical Systems, LP · 2016 · 3 generations on13descendants
- K191761Mobius3DVarian Medical Systems, Inc. · 2019 · 4 generations on5descendants
- K141800PerfractionSun Nuclear Corporation · 2014 · 2 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K874893 | Model 35300 Tracker (TM) Therapy Beam Evaluator | Keithley Instruments, Inc. | 1988 | — |
| −1 | K972211 | Multidos, QC6PLUS | Ptw-New York Corp. | 1997 | — |
| 0 (this device) | K062817 | PTW David Imrt QC Verification System | Ptw-New York Corp. | 2006 | — |
| +1 | K072374 | Compass | Scanditronix Wellhofer GmbH | 2007 | 3 |
| +2 | K140660 | MOBIUS3D | Mobius Medical Systems, LP | 2014 | 1 |
| +3 | K153014 | Mobius3D | Mobius Medical Systems, LP | 2016 | — |
| +4 | K191761 | Mobius3D | Varian Medical Systems, Inc. | 2019 | — |
| +2 | K141800 | Perfraction | Sun Nuclear Corporation | 2014 | — |
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 |
|---|---|---|
| 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 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 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 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 |
|---|---|---|---|
| * | K972211 | Multidos, QC6PLUSSummary page 1…July 18, 2006 2. Trade/Proprietary Name: PTW DAVID Common/Usual Name: IMRT QC check device 3. Predicate Device(s): PTW QC6PIus, K97221 1 4. Description(s) of Device: The PTW DAVID system MLC-29 is a transparent, segmented, multi-wire ionization… | 1997 |
What descends from it? (33)
See all 333 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 18 years and passes through 2 companies; a new generation was cleared every 9.6 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K072374 (Scanditronix Wellhofer GmbH, 2007) has gone furthest, with 31 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The PTW DAVID is a transparent multiple wire or multiple segment ionization chamber with attached electronics. It is intended to be used as an IMRT QC check device to make verification measurements and provide documentation of the leaf positions and doses from medical accelerators used for IMRT radiotherapy sequences. Data acquired by the PTW DAVID is used to compare and to verify a treatment dose to a prescribed dose and to compile radiation beam data, consistency, over time as part of a quality assurance program.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K062817 · printed Nov 4, 2026
Cite this page
510(k) Report. “K062817: PTW David Imrt QC Verification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K062817
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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