510(k) · Cleared
ClearedDose Verification System Patient Dosimetry System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sicel Technologies, Inc. · NZT Dosimeter, Ionizing Radiation, Implanted
Cleared on Jan 23, 2008 as substantially equivalent to K052118 (Sicel Technologies, Inc., 2006) and 2 other predicates after a 21-day review. Its family tree reaches back 6 generations to 2001. 5 later devices descend from it.
- Decided
- Jan 23, 2008
- Review
- 21 days
- Class
- Class II
- Product code
- NZT
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K011332 (2001). 12 ancestors in all, the oldest K925416 (1993). 5 later devices descend from it, 1 citing it directly.
- Root · 6 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 5 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 4 generations backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- 3 generations backK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- 2 generations backK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- 1 generation backK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
- This deviceK080004 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- Descendant · cites it directly · 4 of its ownK083035 Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008
- Descendant · 2 generations on · 3 of its ownK141154 Oartrac SystemRadiadyne · 2014
- Descendant · 3 generations on · 2 of its ownK150719 OARtrac System with Skin SensorsRadiadyne, LLC · 2015
- Descendant · 3 generations on · 1 of its ownK162954 OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017
- Descendant · 4 generations on · 0 of its ownK182395 OARtrac SystemRadialdyne, LLC · 2019 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K083035Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008 · cites it directly4descendants
- K141154Oartrac SystemRadiadyne · 2014 · 2 generations on3descendants
- K150719OARtrac System with Skin SensorsRadiadyne, LLC · 2015 · 3 generations on2descendants
- K162954OARtrac System with Patient Specific Reusable Universal PSD SensorsRadiadyne, LLC · 2017 · 3 generations on1descendant
- K182395OARtrac SystemRadialdyne, LLC · 2019 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −5 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −4 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| −3 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| −2 | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS… | Sicel Technologies, Inc. | 2006 | — |
| −1 | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS… | Sicel Technologies, Inc. | 2007 | — |
| 0 (this device) | K080004 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| +1 | K083035 | Dose Verification System Patient Dosimetry System | Sicel Technologies, Inc. | 2008 | — |
| +2 | K141154 | Oartrac System | Radiadyne | 2014 | — |
| +3 | K150719 | OARtrac System with Skin Sensors | Radiadyne, LLC | 2015 | — |
| +3 | K162954 | OARtrac System with Patient Specific Reusable Universal PSD Sensors | Radiadyne, LLC | 2017 | — |
| +4 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K052118 | Dose Verification SystemSummary page 2…f I- Comparison with Predicate Device: The intended use of this SICEL DVS is identical to the predicate device, the DVS Dose Verification System in K052118, K061051, and K071399. The indications for use of the SICEL DVS also are the same. The technological features of the SICEL DVS Do… | 2006 |
| * | K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool…Summary page 1510(k) Summary I2 Predicate Device(s): Sicel Technologies, Inc. K0521118,K061051,K071399 DVS, Dose Verification System Device Description: The DVS, Dose Verification System consists of four sub-systems: the DV… | 2006 |
| * | K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool…Summary page 1510(k) Summary I2 Predicate Device(s): Sicel Technologies, Inc. K0521118,K061051,K071399 DVS, Dose Verification System Device Description: The DVS, Dose Verification System consists of four sub-systems: the DVS Impla… | 2007 |
What descends from it? (5)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K083035 | Dose Verification System Patient Dosimetry System | 2008 | 4 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.0 years on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K083035 (Sicel Technologies, Inc., 2008) has gone furthest, with 4 descendants of its own.
- 3 other devices also cite its predicate K052118.
How does its category compare?
All NZT devicesNZT Dosimeter, Ionizing Radiation, Implanted: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 DVS (Dose Verification System) is intended for use in radiation therapy to
verify treatment planning and radiation dose to tissue and organs in or near the
irradiated areas of a patient.
The DVS system is specifically indicated for breast and prostate cancer to
measure photon beam therapy and as an adjunct to treatment planning to permit
measurement of the in vivo radiation dose received at the tumor periphery, tumor
bed and/or surrounding normal tissues for validation of the prescribed dose.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080004 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080004: Dose Verification System Patient Dosimetry System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080004
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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