510(k) · Cleared
ClearedLiac HWL
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sit Sordina Iort Technologies Spa · IYE Accelerator, Linear, Medical
Cleared on Jun 11, 2018 as substantially equivalent to K110840 (Sordina S.P.A., 2012) and 1 other predicate after a 258-day review. Its family tree reaches back 4 generations to 1985. 1 later device descends from it.
- Decided
- Jun 11, 2018
- Review
- 258 days
- Class
- Class II
- Product code
- IYE
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K852907 (1985). 5 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK852907 Siemens Mevatron MESiemens Medical Laboratories, Inc. · 1985
- 3 generations backK981112 MobetronIntraop Medical, Inc. · 1998 · Recalled
- 2 generations backK990209 NOVAC7Hitesys S.P.A. · 2000
- 1 generation backK112286 NOVAC 11New Radiant Technology S.P.A. · 2012
- This deviceK172961 Liac HWLSit Sordina Iort Technologies Spa · 2018
- Descendant · cites it directly · 0 of its ownK182374 LIAC SSit Sordina Iort Technologies Spa · 2019
Most influential descendants
Showing 1 of 1 · See all- K182374LIAC SSit Sordina Iort Technologies Spa · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K852907 | Siemens Mevatron ME | Siemens Medical Laboratories, Inc. | 1985 | — |
| −3 | K981112 | Mobetron | Intraop Medical, Inc. | 1998 | 1 |
| −2 | K990209 | NOVAC7 | Hitesys S.P.A. | 2000 | — |
| −1 | K112286 | NOVAC 11 | New Radiant Technology S.P.A. | 2012 | — |
| 0 (this device) | K172961 | Liac HWL | Sit Sordina Iort Technologies Spa | 2018 | — |
| +1 | K182374 | LIAC S | Sit Sordina Iort Technologies Spa | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (2)
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.
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K182374 | LIAC S | 2019 | 0 |
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 33 years and passes through 5 companies; a new generation was cleared every 11.8 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K182374 (Sit Sordina Iort Technologies Spa, 2019) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IYE devicesIYE Accelerator, Linear, Medical: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
LIAC HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites. The LTAC HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm. The devices must be sold by or on the order of a physician. They are not for use…
Read the full statement (118 words)
LIAC HWL are mobile electron linear accelerators for intra-operative radiotherapy (IORT). Known as intraoperative radiation therapy (IORT), this technique allows delivery of high doses of radiation directly aimed at tumors or other sites.
The LTAC HWL are meant to be used for radiotherapy in the operating theatre on a patient to which the surgeon has just removed a neoplasm.
The devices must be sold by or on the order of a physician. They are not for use by the general public or over-the-counter.
LIAC HWL are clectron accelerators that can work in an operating theater respecting its specific characteristics in terms of cleaning possibility, noise and heat dissipation; in particular, they do not require to move the patient.
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/K172961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172961: Liac HWL.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172961
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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