510(k) · Cleared
ClearedVerisuite 1.6, Verisuite-Particle 1.6
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medcom GmbH · IYE Accelerator, Linear, Medical
Cleared on May 9, 2008 as substantially equivalent to K072506 (Brainlab AG, 2007) and 2 other predicates after a 53-day review. Its family tree reaches back 5 generations to 1981. 5 later devices descend from it.
- Decided
- May 9, 2008
- Review
- 53 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K803130 (1981). 24 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK803130 Multix U. Bucky Table X-Ray UnitSiemens Corp. · 1981 · Recalled
- 4 generations backK971452 Multix Top/Pro Radiographic X-Ray TableSiemens Medical Solutions USA, Inc. · 1997 · Recalled
- 3 generations backK983732 Thorax FD and Multix FDSiemens Medical Solutions USA, Inc. · 1999 · Recalled
- 2 generations backK992794 Stingray DR, Model 1Infimed, Inc. · 1999
- 1 generation backK024147 Paxscan 4030 Medical Digital Imaging SystemVarian Medical Systems, Inc. · 2003
- This deviceK080742 Verisuite 1.6, Verisuite-Particle 1.6Medcom GmbH · 2008
- Descendant · cites it directly · 3 of its ownK092653 Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009
- Descendant · 2 generations on · 2 of its ownK133914 Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH · 2014
- Descendant · 2 generations on · 0 of its ownK181789 VeriSuiteMedcom GmbH · 2018
- Descendant · 3 generations on · 0 of its ownK171049 Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare · 2017
- Descendant · cites it directly · 0 of its ownK132847 I2CIon Beam Applications S.A. · 2013 · Recalled
Most influential descendants
Showing 5 of 5 · See all- K092653Verisuite and Verisuite-Particle, Version 1.8Medcom GmbH · 2009 · cites it directly3descendants
- K133914Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-ParticleMedcom GmbH · 2014 · 2 generations on2descendants
- K181789VeriSuiteMedcom GmbH · 2018 · 2 generations on0descendants
- K171049Real Time Image Gating System for Proton Beam Therapy SystemsHitachi, Ltd. Healthcare · 2017 · 3 generations on0descendants
- K132847I2CIon Beam Applications S.A. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K803130 | Multix U. Bucky Table X-Ray Unit | Siemens Corp. | 1981 | 1 |
| −4 | K971452 | Multix Top/Pro Radiographic X-Ray Table | Siemens Medical Solutions USA, Inc. | 1997 | 8 |
| −3 | K983732 | Thorax FD and Multix FD | Siemens Medical Solutions USA, Inc. | 1999 | 1 |
| −2 | K992794 | Stingray DR, Model 1 | Infimed, Inc. | 1999 | — |
| −1 | K024147 | Paxscan 4030 Medical Digital Imaging System | Varian Medical Systems, Inc. | 2003 | — |
| 0 (this device) | K080742 | Verisuite 1.6, Verisuite-Particle 1.6 | Medcom GmbH | 2008 | — |
| +1 | K092653 | Verisuite and Verisuite-Particle, Version 1.8 | Medcom GmbH | 2009 | — |
| +2 | K133914 | Verisuite 1.8, Verisuite-Particle 1.8, Verisuite, Verisuite-Particle | Medcom GmbH | 2014 | — |
| +2 | K181789 | VeriSuite | Medcom GmbH | 2018 | — |
| +3 | K171049 | Real Time Image Gating System for Proton Beam Therapy Systems | Hitachi, Ltd. Healthcare | 2017 | — |
| +1 | K132847 | I2C | Ion Beam Applications S.A. | 2013 | 3 |
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 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 IYE? 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 IYE device
- #1 K252977 Halcyon, Ethos Radiotherapy System (5.0)score 18.8 · 18 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K072506 | Exactrac 5.5Summary page 1…te-Particle 1.6 D. Predicate device Device trade name: EXACTRAC 5.5 / ExacTrac X-RAY 6D 510(k) number: K072506 Company name: BRAINLAB AG Classification Number: 892.5050 Cl… | 2007 |
| * | K024147 | Paxscan 4030 Medical Digital Imaging SystemSummary page 2…Classification Number: 892.1630 Classification: Class II Product Code: MQB 510(k) Number: K024147 Collimator, Ralco 302 Classification name: Device, Beam Limiting, X-ray Solid State… | 2003 |
| * | K946320 | R 302Summary page 2…ation Number: 892.1610 Classification: Class II Product Code: KPW 510(k) Number: K946320 Document: MC.5024.MSC.2100.0001.A ©MedCom GmbH 2008 File: MC.5024.MSC.2100.FDAC… | 1995 |
| * | — | X-Ray Generator, Sedecal SHF 835 Named without a submission number | |
| * | — | X-Ray Tubes, Varian A277 / A272 Named without a submission number |
What descends from it? (5)
2 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 27 years and passes through 5 companies; a new generation was cleared every 3.3 years on median.
- 11 of the 24 ancestors have a recall of any class.
- Of its descendants, K092653 (Medcom GmbH, 2009) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K072506.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · IYE
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYE
170in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYE
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IYE
101in 2025
MAUDE reports naming product code IYE, 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 | 23 | 44 | 78 | 155 |
| 2008 | 14 | 69 | 49 | 114 |
| 2009 | 20 | 63 | 22 | 174 |
| 2010 | 23 | 74 | 27 | 246 |
| 2011 | 11 | 94 | 73 | 280 |
| 2012 | 28 | 106 | 20 | 128 |
| 2013 | 18 | 88 | 11 | 96 |
| 2014 | 20 | 100 | 14 | 124 |
| 2015 | 20 | 108 | 8 | 100 |
| 2016 | 21 | 97 | 7 | 97 |
| 2017 | 23 | 94 | 7 | 125 |
| 2018 | 21 | 58 | 7 | 85 |
| 2019 | 19 | 83 | 2 | 91 |
| 2020 | 20 | 67 | 4 | 74 |
| 2021 | 19 | 86 | 5 | 68 |
| 2022 | 12 | 172 | 3 | 66 |
| 2023 | 18 | 129 | 7 | 128 |
| 2024 | 9 | 239 | 1 | 81 |
| 2025 | 12 | 170 | 1 | 101 |
| 2026 | 14 | 120 | 4 | — |
What is it indicated for?
The VeriSuite patient position verification system is used for verification and correction of the patient's position during a radiotherapy treatment with external beams or charged particles. It is based on stereoscopic X-ray images and DRRs calculated from a CT image series of the treatment region of the patient and information from the treatment planning.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080742 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080742: Verisuite 1.6, Verisuite-Particle 1.6.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080742
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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