510(k) · Cleared
ClearedDose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS Dosimeter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sicel Technologies, Inc. · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Jun 13, 2006 as substantially equivalent to K052118 (Sicel Technologies, Inc., 2006) after a 57-day review. Its family tree reaches back 4 generations to 2001. 7 later devices descend from it.
- Decided
- Jun 13, 2006
- Review
- 57 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K011332 (2001). 10 ancestors in all, the oldest K925416 (1993). 7 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 3 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 2 generations backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- 1 generation backK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- This deviceK061051 Dose Verification System Patient Dosimetry System, Models DVS-I-11…Sicel Technologies, Inc. · 2006
- Descendant · cites it directly · 6 of its ownK071399 Dose Verification System Patient Dosimetry System, Model DVS-I-11…Sicel Technologies, Inc. · 2007
- Descendant · cites it directly · 5 of its ownK080004 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
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K071399Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool…Sicel Technologies, Inc. · 2007 · cites it directly6descendants
- K080004Dose Verification System Patient Dosimetry SystemSicel Technologies, Inc. · 2008 · cites it directly5descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −3 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −2 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| −1 | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| 0 (this device) | 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 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 2 | 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 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 |
|---|---|---|---|
| * | K052118 | Dose Verification SystemSummary page 2…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): K & Sicel Technologies, Inc. K052118 DVS, Dose Verification System Device Description: The DVS, Dose Verification System consists of four sub-systems: the DVS Impl… | 2006 |
What descends from it? (7)
3 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 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 10 ancestors has a recall.
- Of its descendants, K071399 (Sicel Technologies, Inc., 2007) has gone furthest, with 6 descendants of its own.
- 3 other devices also cite its predicate K052118.
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?
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061051: Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool, DVS-D-a, DVS Dosimeter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061051
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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