510(k) · Cleared
Cleared0.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization Chamber
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) after a 90-day review. Its family tree reaches back 1 generation to 1995. 1 later device descends from it.
- Decided
- Sep 10, 1997
- Review
- 90 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K954165 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 1 generation backK954165 PTW-MP3 & PTW-MP3S Automatic Water PhantomPtw-New York Corp. · 1995
- This deviceK972212 0.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization…Ptw-New York Corp. · 1997
- Descendant · cites it directly · 0 of its ownK112981 Sun 125C Ionization ChamberSun Nuclear Corp. · 2012
Most influential descendants
Showing 1 of 1 · See all- K112981Sun 125C Ionization ChamberSun Nuclear Corp. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K954165 | PTW-MP3 & PTW-MP3S Automatic Water Phantom | Ptw-New York Corp. | 1995 | — |
| 0 (this device) | K972212 | 0.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization Chamber | Ptw-New York Corp. | 1997 | — |
| +1 | K112981 | Sun 125C Ionization Chamber | Sun Nuclear Corp. | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 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 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? (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 |
|---|---|---|---|
| * | K954165 | PTW-MP3 & PTW-MP3S Automatic Water PhantomSummary page 1…mon/Usual Name: 0.015 cc waterproof ionization chamber, 0.005 cc waterproof ionization chamber. Predicate Device(s): PTW T31002, 0.125 cc waterproof ionization chamber, K954165, and PTW T31003, 0.03 cc waterproof ionization chamber, K954165. Description of Device(s): The PTW T31006 and T31007 are classic… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K112981 | Sun 125C Ionization Chamber | 2012 | 0 |
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?
High quality ionization chambers, like the PTW T31006 and T31007 Pinpoint type ionization chambers make it possible to routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision. This type of lonization chamber is intended to be used for the collection of radiation beam data from radiation therapy treatment machines in water, air, or other suitable solid state phantoms.…
Read the full statement (172 words)
High quality ionization chambers, like the PTW T31006 and T31007 Pinpoint type ionization chambers make it possible to routinely measure, record, and document therapeutic amounts of ionizing radiation with an exceptionally high degree of accuracy and precision.
This type of lonization chamber is intended to be used for the collection of radiation beam data from radiation therapy treatment machines in water, air, or other suitable solid state phantoms. Since the T31006 and T31007 Pinpoint chambers are waterproof, they are ideally suited for measurements of high energy photons and electrons in a water phantom.
The data acquired with this type of chamber can be used to completely document the beam characteristics of treatment machines, compile radiation beam data over time as part of a quality assurance program, and to establish an initial baseline for the radiation therapy beams generated by the treatment unit.
High quality ionization chambers, like the PTW Pinpoint type chambers, 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/K972212 · printed Nov 4, 2026
Cite this page
510(k) Report. “K972212: 0.015CC Pinpoint Ionization Chamber, 0.005 CC Pinpoint Ionization Chamber.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K972212
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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