510(k) · Cleared
ClearedVeriSuite
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcom GmbH · LHN System, Radiation Therapy, Charged-Particle, Medical
Cleared on Sep 21, 2018 as substantially equivalent to K092653 (Medcom GmbH, 2009) and 2 other predicates after a 78-day review. Its family tree reaches back 8 generations to 1981.
- Decided
- Sep 21, 2018
- Review
- 78 days
- Class
- Class II
- Product code
- LHN
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K803130 (1981). 30 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 7 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 6 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 5 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 4 generations backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- 3 generations backK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- 2 generations backK092653 Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009
- 1 generation backK133914 Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH · 2014
- This deviceK181789 VeriSuiteMedcom GmbH · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −7 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −6 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −5 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −4 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| −3 | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| −2 | K092653 | Verisuite and Verisuite-Particle, Version 1.8 | Medcom GmbH | 2009 | — |
| −1 | K133914 | Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle | Medcom GmbH | 2014 | — |
| 0 (this device) | K181789 | VeriSuite | Medcom GmbH | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 3 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 2 | 0 |
| 2012 | 2 | 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? (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 |
|---|---|---|---|
| * | K092653 | Verisuite and Verisuite-Particle, Version 1.8Summary page 5…Page 5 of 38 C. Predicate Devices Device trade name: VeriSuite 1.8 510(k) number: K092653 Company name: MedCom GmbH Classification Number: 892.5050 Classifi… | 2009 |
| * | K122451 | Exactrac VeroSummary page 5…e: LHN Subsequent code: IYE Device trade name: EXACTRAC VERO 510(k) number: K122451 Company name: BRAINLAB AG Classification Number: 892.5050 Classifi… | 2012 |
| * | K133914 | Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleSummary page 7…device VeriSuite® 2.3 (build number B100.48, subject of this submission) is substantially equivalent to the predicate device VeriSuite® 1.8 (K133914) except the 3D3D extension. The 3D3D extension of VeriSuite® is substantially equivalent to the 3D3D… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 5 companies; a new generation was cleared every 4.5 years on median.
- 13 of the 30 ancestors have a recall of any class.
- 1 other device also cites its predicate K092653.
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. 2018, this device’s year, is highlighted.
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?
VeriSuite is an image processing software for verification of the patient position and calculation of a correction vector for the treatment of tumors during a radiation therapy with photons, electrons (from a linear accelerator) or particles (protons).
An authorized person must evaluate the correctness of the calculation and approve the result for further usage. The system shall only be used after correct installation in appropriate treatment rooms by trained personnel. Legal regulations especially regulation for the operation of X-ray devices must be regarded.
VeriSuite must not be used for diagnostic purposes.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181789 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181789: VeriSuite.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181789
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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