510(k) · Cleared
ClearedOARtrac System with Skin Sensors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radiadyne, LLC · NZT Dosimeter, Ionizing Radiation, Implanted
Cleared on Jun 16, 2015 as substantially equivalent to K141154 (Radiadyne, 2014) after an 89-day review. Its family tree reaches back 9 generations to 2001. 2 later devices descend from it.
- Decided
- Jun 16, 2015
- Review
- 89 days
- Class
- Class II
- Product code
- NZT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K011332 (2001). 16 ancestors in all, the oldest K925416 (1993). 2 later devices descend from it, 1 citing it directly.
- Root · 9 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 5 generations between
- 3 generations backK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 2 generations backK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 1 generation backK141154 Oartrac SystemRadiadyne · 2014
- This deviceK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- Descendant · cites it directly · 1 of its ownK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK182395 OARtrac SystemRadialdyne, LLC · 2019 · Recalled
Show all 9 generations
- Root · 9 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 8 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 7 generations backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- 6 generations backK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- 5 generations backK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- 4 generations backK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
- 3 generations backK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 2 generations backK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 1 generation backK141154 Oartrac SystemRadiadyne · 2014
- This deviceK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −8 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −7 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| −6 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| −5 | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS… | Sicel Technologies, Inc. | 2006 | — |
| −4 | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS… | Sicel Technologies, Inc. | 2007 | — |
| −3 | K080004 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| −2 | K083035 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| −1 | K141154 | Oartrac System | Radiadyne | 2014 | — |
| 0 (this device) | K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015 | — |
| +1 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017 | — |
| +2 | K182395 | OARtrac System | Radialdyne, LLC | 2019 | 5 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2019 | 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 NZT? 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 NZT device
- #1 K250083 PRO-DOSE Systemscore 10.1 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | K141154 | Oartrac SystemSummary page 4…NZT Device Class: Class II Classification Panel: Radiology 5. Legally Marketed Predicate Device RadiaDyne, LLC OARtrac® System (K141154) 6. Device Description The OARtrac® System with Skin Sensors provides Radiation Oncologists with near real-time, multi-poi… | 2014 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | 2017 | 1 |
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 14 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- None of the 16 ancestors has a recall.
- Of its descendants, K162954 (Radiadyne, LLC, 2017) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K141154.
How does its category compare?
All NZT devicesNZT Dosimeter, Ionizing Radiation, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · NZT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NZT
Too few NZT 510(k)s in any year since 2007 to give a median.
Recalls per year · NZT
5in 2019
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NZT
No MAUDE report names NZT since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 5 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The OARtrac® System pre-calibrated skin sensors are specifically indicated for use during cancer treatments to measure
photon beam therapy as an adjunct to treatment planning permitting measurement of radiation dose received on the
surface of the skin. OARtrac® System pre-calibrated skin sensors are indicated for use when adhered to the surface of the
skin using medical grade adhesive and with a medical grade bolus buildup placed directly on top of the sensor.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150719: OARtrac System with Skin Sensors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150719
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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