510(k) · Cleared
Recalled · Class II · 2019OARtrac System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Radialdyne, LLC · NZT Dosimeter, Ionizing Radiation, Implanted
Cleared on Mar 22, 2019 as substantially equivalent to K162954 (Radiadyne, LLC, 2017) after a 199-day review. Its family tree reaches back 11 generations to 2001. It has been recalled 5 times.
- Decided
- Mar 22, 2019
- Review
- 199 days
- Class
- Class II
- Product code
- NZT
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 11 generations to K011332 (2001). 18 ancestors in all, the oldest K925416 (1993). No later device cites it as a predicate yet.
- Root · 11 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 7 generations between
- 3 generations backK141154 Oartrac SystemRadiadyne · 2014
- 2 generations backK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- 1 generation backK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- This deviceK182395 OARtrac SystemRadialdyne, LLC · 2019
Show all 11 generations
- Root · 11 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 10 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 9 generations backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- 8 generations backK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- 7 generations backK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- 6 generations backK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
- 5 generations backK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 4 generations backK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- 3 generations backK141154 Oartrac SystemRadiadyne · 2014
- 2 generations backK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- 1 generation backK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- This deviceK182395 OARtrac SystemRadialdyne, LLC · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −10 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −9 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| −8 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| −7 | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS… | Sicel Technologies, Inc. | 2006 | — |
| −6 | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS… | Sicel Technologies, Inc. | 2007 | — |
| −5 | K080004 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| −4 | K083035 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| −3 | K141154 | Oartrac System | Radiadyne | 2014 | — |
| −2 | K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015 | — |
| −1 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017 | — |
| 0 (this device) | K182395 | OARtrac System | Radialdyne, LLC | 2019 | — |
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 |
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 |
|---|---|---|---|
| * | K162954 | OARtrac System with Patient Specific Reusable Universal PSD SensorsSummary page 4…ry Class: II Classification Panel: Radiology 5. Legally Marketed Predicate Device(s) Radiadyne OARtrac® System with Patient Specific Reusable PSD Sensors, K162954 6. Device Description The OARtrac® System with patient specific, reusable up to five times, pre-calibrated PSD sensors is… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 19, 2019 | Class II | Z-0709-2020 | Under Investigation by firm | May result in readings outside of the expected accuracy range. |
| Nov 19, 2019 | Class II | Z-0712-2020 | Under Investigation by firm | May result in readings outside of the expected accuracy range. |
| Nov 19, 2019 | Class II | Z-0710-2020 | Under Investigation by firm | May result in readings outside of the expected accuracy range. |
| Nov 19, 2019 | Class II | Z-0711-2020 | Under Investigation by firm | May result in readings outside of the expected accuracy range. |
| Nov 19, 2019 | Class II | Z-0713-2020 | Under Investigation by firm | May result in readings outside of the expected accuracy range. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 18 years and passes through 5 companies; a new generation was cleared every 1.0 years on median.
- None of the 18 ancestors has a recall.
How does its category compare?
All NZT devicesNZT Dosimeter, Ionizing Radiation, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 with patient specific, reusable up to five times, pre-calibrated PSD sensors are intended for use during cancer treatments to measure photon and electron radiation therapy as an adjunct to treatment planning permitting measurement and validation of radiation dose received by the patient to the targeted area of their body. The system is indicated for use with electron energy when adhered to the skin with or without a bolus, and for photon energy when adhered to the skin with a minimum 3mm bolus or inserted into the rectum for measurements at the rectal wall during cancer treatment via a specifically designed OARtrac® endorectal balloon device.
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/K182395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K182395: OARtrac System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K182395
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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