510(k) · Cleared
ClearedDose Verification System
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 Apr 3, 2006 as substantially equivalent to K932598 (Keithley Instruments, Inc., 1994) and 6 other predicates after a 242-day review. Its family tree reaches back 3 generations to 2001. 8 later devices descend from it.
- Decided
- Apr 3, 2006
- Review
- 242 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 3 generations to K011332 (2001). 9 ancestors in all, the oldest K925416 (1993). 8 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK011332 RF-Ivd Wireless Dosimeter-Model 1133Sun Nuclear Corp. · 2001
- 2 generations backK021463 Model 1133 Ivd PC VersionSun Nuclear Corp. · 2002
- 1 generation backK040687 Onedose Patient Dosimetry SystemSicel Technologies, Inc. · 2004
- This deviceK052118 Dose Verification SystemSicel Technologies, Inc. · 2006
- Descendant · cites it directly · 7 of its ownK061051 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
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061051Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool…Sicel Technologies, Inc. · 2006 · cites it directly7descendants
- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011332 | RF-Ivd Wireless Dosimeter-Model 1133 | Sun Nuclear Corp. | 2001 | — |
| −2 | K021463 | Model 1133 Ivd PC Version | Sun Nuclear Corp. | 2002 | — |
| −1 | K040687 | Onedose Patient Dosimetry System | Sicel Technologies, Inc. | 2004 | — |
| 0 (this device) | K052118 | Dose Verification System | Sicel Technologies, Inc. | 2006 | — |
| +1 | 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 | — |
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 |
|---|---|---|
| 2006 | 1 | 0 |
| 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? (7)
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 |
|---|---|---|---|
| * | K932598 | TN-RD-50Summary page 2…risville, NC 27560 Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): Thomson Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sice… | 1994 |
| * | K013279 | Mosfet Autosense, Model TN-RD-60Summary page 2…NC 27560 Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): Thomson Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technol… | 2001 |
| * | K010472 | Patient Dose Verification System, Model TN-RD-50Summary page 2…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): Thomson Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technologies, In… | 2001 |
| * | K032725 | Mosfet Autosense WirelessSummary page 2…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): Thomson Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technologies, Inc. K04068… | 2003 |
| * | K041557 | Mobilemosfet Wireless Dosimetry System, Model TN-RD-70-WSummary page 2…Phone: (919) 465-2236 Fax: (919) 465-0153 Predicate Device(s): Thomson Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technologies, Inc. K040687 OneDose Pat… | 2004 |
| * | K040687 | Onedose Patient Dosimetry SystemSummary page 2…son Nielsen K932598, K013279, K010472, K032725, and K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technologies, Inc. K040687 OneDose Patient Dosimetry System Symbiosis K925416 Bone Biopsy Needle Device Description: The DVS, Dose Verification System co… | 2004 |
| * | K925416 | Symbiosis Bone Marrow Biopsy NeedleSummary page 2…K041557 TN-RD-50, MOSFET Autosense Wireless Dosimetry System, mobileMOSFET Dosimetry System Sicel Technologies, Inc. K040687 OneDose Patient Dosimetry System Symbiosis K925416 Bone Biopsy Needle Device Description: The DVS, Dose Verification System consists of four sub-systems: the DVS Implantable Dosi… | 1993 |
What descends from it? (8)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061051 | Dose Verification System Patient Dosimetry System, Models DVS-I-11, DVS Insertion Tool… | 2006 | 7 |
| K071399 | Dose Verification System Patient Dosimetry System, Model DVS-I-11: DVS Insertion Tool… | 2007 | 6 |
| K080004 | Dose Verification System Patient Dosimetry System | 2008 | 5 |
| 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 5 years and passes through 2 companies; a new generation was cleared every 1.8 years on median.
- None of the 9 ancestors has a recall.
- Of its descendants, K061051 (Sicel Technologies, Inc., 2006) has gone furthest, with 7 descendants of its own.
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 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/K052118 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052118: Dose Verification System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052118
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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